Catalog Number 381023 |
Device Problems
Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that foreign matter was found in the bd vacutainer® serum blood collection tube packaging seal before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "fm is in the sealing part.".
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Manufacturer Narrative
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H.6.Investigation: bd received two 22 gauge insyte autoguard blood control units from lot 8268697 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed traces of the packaging trim caught inside of the packaging seal.Based off the visual inspection the engineer was able to verify the reported defect.The packaging trim can be caught inside of the seal if it doesn't get removed properly with the vacuum.
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Event Description
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It was reported that foreign matter was found in the bd vacutainer® serum blood collection tube packaging seal before use.The following information was provided by the initial reporter, translated from japanese to english: "fm is in the sealing part.".
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Search Alerts/Recalls
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