Qn# (b)(4).A device history record review was performed on the outer tray and kit with a potentially relevant finding.Per a nonconformance during incoming inspection for outer tray t-05600-100b (lot#23p19a0261), a white powder residue observed on some of the trays.A rework was performed to remove the residue and the trays were re-inspected and accepted.This is not relevant to this complaint.The customer reported the outer tray of the kit cracking potentially causing sterility issues.The customer returned one sealed kit.Visual examination of the returned kit revealed the upper left and right corners show signs of stress.Also, the upper left corner is cracked under the flange.No other defects or anomalies were observed.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Per the manufacturing site, all incoming outer trays are visually inspected for evidence of stress marks prior to packaging as well as each packaged kit is inspected after sealing and prior to being placed into the corrugate container.Also, packaging and engineering personnel attempted to duplicate opening sealed kits but concluded significate manual force is needed to crack one or more of the corners of the kit.The reported complaint of the tray is cracking was confirmed based on the sample received.Visual inspection of the returned kit revealed the upper left and right corners showed signs of stress as well as the lower left corner having crack under the flange.A device history record review was performed on the outer tray and kit with no relevant findings.Also, the outer trays are 100% inspected prior to and after packaging.It is unknown how the kit was handled during shipping or prior to use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the tray's corners being stressed, and cracking could not be determined.
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