Catalog Number 6AC4466 |
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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The event occurred on an unspecified date in (b)(6) 2020.Expiration date: 01/2022.The device has been received and the evaluation is in progress.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 the aluminum foil of thirty-seven (37) minicaps had "air leakage" (lacked good seal).This was observed before use for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Thirty-seven (37) samples were received for evaluation.Visual inspection was performed and found the sealings of the samples were not stuck well.The reported condition was verified.The cause of the condition was found to be supplier manufacturing related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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