Received one used list # (b)(6), zytomed-verabreichungs-set onko ii; lot #4096749, two used unknown infusions sets, and one chemoclave bag spike (unknown list and lot#) and were visually inspected.As received, the spiros of list # (b)(6) add-on set was disconnected from the male luer adapter.Per the product design configuration for list # (b)(6) the spiros should be bonded to the male luer adaptor.Little to no solvent was present on the disconnected components.No other damage or anomalies were identified.The reported complaint can be confirmed.The probable cause is due to an error during manual assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 5/12/2022, e1 - initial reporter phone: (b)(6).
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