This report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples with no packaging were returned for evaluation.The samples were visually evaluated, and it was noted that 1 out 2 samples were confirmed to have the patient connector broken off inside a straight body caresite valve.Unfortunately, due to contamination reasons both samples needed to be scrapped because of possible hiv-positive blood found to be in sets.Based on the evaluation results, the patient connector was broken off inside the y-care site.Although the exact root cause cannot be determined, previous engineering testing cited a probable root cause could be alcohol exposure of certain male adapters, which can lead to difficulty removing or breakage of male luer tapers when connected to female luers.Per the ifu it states, "swab top lad vigorously for 15 seconds with 70% isopropyl alcohol and allow to air dry prior to use." review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
|