Catalog Number 381137 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).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 the bd angiocath¿ iv catheter broke off/separated from the hub and caused leakage of blood.The following information was provided by the client: "on (b)(6) the left radial artery puncture tube was found to have oozing blood, and it was pulled out to find that the tube was broken at the connection between the tube and the interface, and a new non-broken disposable indwelling needle was replaced.".
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Manufacturer Narrative
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H.6.Investigation: 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.A review of the device history record was performed and no quality issues were found during production.
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Event Description
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It was reported that the bd angiocath¿ iv catheter broke off/separated from the hub and caused leakage of blood.The following information was provided by the client: "on january 19, the left radial artery puncture tube was found to have oozing blood, and it was pulled out to find that the tube was broken at the connection between the tube and the interface, and a new non-broken disposable indwelling needle was replaced.".
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Search Alerts/Recalls
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