Catalog Number 408394 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/15/2020 |
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.(b)(4).
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Event Description
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It was reported that the bd whitacre¿ needle was found damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the package, it was verified that the needle was bent; damaged.".
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Manufacturer Narrative
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H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
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Event Description
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It was reported that the bd whitacre¿ needle was found damaged before use.The following information was provided by the initial reporter, translated from portuguese to english: "when opening the package, it was verified that the needle was bent; damaged.".
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Search Alerts/Recalls
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