Catalog Number 12673-05 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during device unpackaging, prior to a procedure, when the outer packaging was opened, the inner packaging appeared to be stuck to the outer packaging and was opened.The device was not used and there was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The unsealed packaging was confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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