Faulty Tuohy needle.

Abstract

I was more than astonished to read the reply from Sims Portex Ltd to the letter from Drs Alsahas and Jenkins (Anaesthesia 1999; 54: 511). They had described a faulty Tuohy needle, manufactured by Sims Portex, in which the plastic stylet had been left protruding from the end of the needle. In their response the manufacturers stated ‘that this has been the result of an isolated manufacturing fault’. My astonishment is caused by the fact that I reported an exactly similar misassembled Tuohy needle, directly to the company, in November 1998. Considerable correspondence ensued but I am told by Sims Portex that this problem has existed since 1994 and there have been 12 reported incidents. Of greater concern is their last letter to me in April with the statement that ‘since the introduction of a trimming jig in 1997, we have only received your complaint of over-length stylet set against two and a half million units sold in this period. Because of this very low level of incidence, we do not intend to make any further changes to our production process or quality assurance systems.’ As it is now obvious that there have been at least two recent manufacturing faults, I am concerned that this apparent campaign of secrecy may not bode well for future patient care. Before September 1997, we experienced an incidence of complaints of Tuohy needle stylet protrusion of 1 per 500 000 units sold. This was found to be due to our process operators’ occasional failure to fully engage the stylet in the needle hub prior to trimming off surplus material and we introduced a locating jig to ensure full engagement of the stylet prior to trimming. Following Dr Stevens’ complaint in November 1998, we found that the continuing, albeit now much reduced, incidence of stylet protrusion was due to one of our production operators not using the jig provided. All operators were then re-trained in the use of the trimming jig; however, the manufacture of the product Lot involved in the complaint reported by Drs Alsahas and Jenkins pre-dated this action. We have subsequently improved our inspection procedures in this area and are currently investigating further process improvements. In preparing our response to Dr Stevens, we failed to connect his problem with that of Drs Alsahas and Jenkins and did not make it clear to Dr Stevens that there was one other report which pre-dated our corrective action. This was a genuine error, for which we apologise. We would like to assure readers of Anaesthesia that far from conducting a ‘campaign of secrecy’, SIMS Portex has been very open in volunteering our background of knowledge of other incidents. SIMS Portex Ltd values all feedback from users, as a basis for our continuing product and manufacturing process improvements. D. Poore SIMS Portex Ltd, Hythe, Kent CT21 6JL, UK