Catalog Number 7N8378 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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This event occurred on (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was a packaging issue with a one-link non-dehp standard bore catheter extension set which compromised the sterility of the product.Before patient use, it was discovered that the set was packaged with an additional winged female luer lock adapter component and the packaging had not sealed completely.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.During visual inspection, damage was observed in sterile the blister packaging due to a pinched set and a second set was found inside the sterile blister package.The reported condition was verified.The cause of the event was determined due to the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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