Aspen surgical received a report from the distributor indicating that the seal of a scalpel holder pouch was compromised.The item was not in use and no injury/death was reported.A sample was available for evaluation.A manufacturing lot number was provided for review.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.A review of the sample confirmed that the seal contained a red splice tape that was processed into the packaging.Manufacturing engineering was consulted.During material changes, red splice tape is used to identify the roll stock change on the equipment.Per manufacturing work instructions, the machine is required to run until the splice appears in the loading area.Once this appears, then the initiation of the sealing process begins and the empty pouches are removed.Loading then resumes with the product.Therefore, the root cause contributing to the event was due to operating error.Additionally, the pouch label identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Based on this information, no further action is required.
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