Catalog Number 383019 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2020 |
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 needle core on the bd intima ii¿ iv catheter prn adapter broke from the handle.The following information was provided by the initial reporter, translated from chinese to english: "the nurse prepared to perform indwelling needle puncture for the patient, opened the packaging box of indwelling needle, found that the needle was aslant and the needle core was receding, found that the needle core was broken from the needle handle, and immediately replaced a new indwelling needle without any damage to the patient.".
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Manufacturer Narrative
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H6: 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.
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Event Description
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It was reported that the needle core on the bd intima ii¿ iv catheter prn adapter broke from the handle.The following information was provided by the initial reporter, translated from chinese to english: "the nurse prepared to perform indwelling needle puncture for the patient, opened the packaging box of indwelling needle, found that the needle was aslant and the needle core was receding, found that the needle core was broken from the needle handle, and immediately replaced a new indwelling needle without any damage to the patient.".
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Search Alerts/Recalls
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