(b)(4).This report has been identified as b.Braun melsungen ag internal report # (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are used in products that are sold in the united states by b.Braun medical, inc.We received used catheter and filter, clip, and 2pcs connector out of a perifix filter set.Visual inspection: the catheter is broken 142mm away from tip.The tip of the catheter is kinked and twisted.The catheter was microscopically tested.The catheter resembled a state cut with micro scissors.The catheter is stretched from the tip to the middle.Dimensions check: length: received catheter: 1094mm, standard: 1002.5mm - 1017.5mm, (unused catheter length: 1009mm), the catheter is stretched.We guessed that it was stretched in surgical procedure.Review manufacturing record (perifix filter set).We checked our manufacturing records and any abnormality was not found.We assume a problem during application.This complaint is not confirmed.We have informed our manufacturer of the catheter accordingly and requested a batch review of the involved catheter perifix one.If additional information becomes available, a follow up report will be submitted.
|
Exemption number e2016018.B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).The catheter is cut off.The area of the cut off is oval and shows a rough structure.We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.We assume a problem during application.The complaint is not confirmed.After checking the respective documentation of the production (shift record, results of worker self-inspection and in-process control, machine documentation, cleaning record etc.) no deviations could be identified in the mentioned time period.
|