Report received indicated that a lumbar drainage set was placed on august 27, 1997 in a 50 yr old female patient after craniotomy for tumor removal. On september 2nd, while turning patient in bed, lumbar drainage catheter broke into two pieces, and was removed (without surgical intervention). The drainage system was not replaced. No patient injury or complications were reported.

The following complaint investigation was performed: the involved device was disposed of by the user. Distribution records analysis concluded that the device was a lumbar drainage set catalog n 910-120a, lot #21196023. Complete tracability records of this lot were reviewed: no anomalies were noted. Conclusion: the complaint is unverifiable since no product was returned. It is clear that the system was initially functioning well (6 days implant), and this led co to conclude that the lumbar catheter breakage was caused by excessive forces. In order to avoid this kind of problem, it is common medical practice to secure the catheter/drainage system connection to the bandage in order to prevent any accidental pull force to be applied to the catheter. The device is marketed since prior to 1976, with more than 25000 lumbar catheters sold from january 1994 to date. As no such case of breakage of lumbar catheter during normal use was reported before, and as standard medical practice should prevent such event, no corrective action is deemed required.