Model Number H7493925132300 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the package seal was opened.A 32x3.00 promus premier drug-eluting stent was delivered however it was noted that the outer package seal was opened.The device never entered the patient's body.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was received for analysis and was contained within the carton with the blue closure strip pealed away and some evidence of damage was noted around the carton tab.No issues were identified with the carton label which was fully legible and accurate.The carton was then opened during examination to reveal the foil pouch packaging and dfu.There was no evidence of damage to the foil pouch packaging or the dfu.Sufficient procedures are in place to recognise damaged & compromised product and damaged product packaging at the relevant distribution centres.There was no evidence of compromise to the product sterility or functionality as a result of this issue.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that the package seal was opened.A 32x3.00 promus premier drug-eluting stent was delivered however it was noted that the outer package seal was opened.The device never entered the patient's body.No patient complications were reported.
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Search Alerts/Recalls
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