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Catalog Number SXPP1B410 |
Device Problem
Incorrect Device Or Component Shipped (2962)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual evaluation of the picture, an opened box labeled product code sxpp1b410 could be observed.Additionally, inside box a package foil for product code sxpp1b415 was noted.The cause could not be determined and no further investigation can be conducted since the sample was not returned.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
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Event Description
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It was reported that while prepping for an unknown procedure on (b)(6) 2018 and when opening the box of sutures, the sutures inside were not what was ordered.Another like device was used to complete the procedure.There were no adverse patient consequences reported.
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Manufacturer Narrative
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(b)(4).Device evaluation summary: an opened box of product code (b)(4), lot mcj439 with eleven unopened samples of product code (b)(4) lot mcj625 were returned for analysis.During the visual inspection of box, the cellophane wrap was removed and the box was received opened and contains eleven samples.In addition, no defects were found on the packets.The impression of the box does not match the product inside the box (mismatched).Per the condition of the sample, it could not be determined what may have caused the reported incident.
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Search Alerts/Recalls
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