(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility returned two unopened, unused safeline injection sites from their current inventory.The packaging from the first sample indicated lot number 0061296080 (identified as the reported lot that had the issue); and the packaging from the second sample indicated lot number 0061236187 (identified as an older lot that did not have this issue).Both returned safeline injection sites were inserted through the center with a safeline cannula as per the instructions for use (ifu).The injection sites were then pressurized with a syringe filled with water.During this time, there were no leakages observed on either injection site.Based on the information provided by the reporting facility, it was stated that the injectio site was accessed with a needle.Per the ifu, the safeline injection site is intended to be used with the b.Braun safeline system.The septum of the safeline injection site contains a pre-pierced slit and is designed to be used with a safeline cannula.The safeline cannula is to be inserted to the appropriate device through the center of the septum.This device is not intended to be used with a needle.Medication additions requiring a conventional needle should be used in emergency situations only.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature noted during in-process or final product inspection.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.
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