Qn#(b)(4) per dhr the product horizon ti ml 6/cart 120/box lot# 73m2100251 was manufactured on 12/13/2021 a total of (b)(4)pieces.Lot was released on 01/11/2022.Dhr investigation did not show issues related to complaint.The customer provided two photos for analysis; reference pic1_tc# 1900094048 for the customer supplied photos.The complaint of broken package - sterility compromised was able to be confirmed by the photo.The customer returned one sample of 003200 horizon ti ml 6/cart 120/box for investigation.The returned sample was unopened in its original packaging.Visual inspection revealed a crack along one corner of the packaging, including the sterile seal.The reported defect was confirmed.All horizon clips are subjected to 100% inspection for proper packaging, as well as qc inspection based on aql.It is unlikely that this type of damage was present when the sample left the manufacturing facility.Manufacturing was contacted as part of this complaint investigation.Manufacturing stated that the mark/bend present on the sterile sealing was characteristic of a shipping issue.Therefore, the packaging appears to have been damaged during shipping/handling.A corrective action is not required at this time as the packaging appears to have been damaged during shipping/handling.The reported complaint of "broken package - sterility compromised" was confirmed based upon the sample received.Visual inspection revealed a crack along one corner of the packaging, including the sterile seal.All horizon clips are 100% inspected at manufacturing.It is unlikely that this type of damage was present when the sample left the manufacturing facility.Therefore, the packaging appears to have been damaged during shipping/handling after it left the control of teleflex.Teleflex will continue to monitor and trend on complaints of this nature.
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