(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the packaging was torn.A device history record review was performed and no relevant findings were identified.Based on the visual exam, the reported complaint was confirmed.In the current manufacturing procedure, a 100% visual inspection is conducted at the packing area.Any defective products would be detected prior to release from the manufacturing facility.The ifu states not to use if the package is broken and storage instructions mention not to use if the product sterilization barrier or packaging is compromised.Although the complaint was confirmed, a root cause could not be established.It is most likely that the issue occurred due to mishandling of the product; however, this could not be confirmed.
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