BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD WHITACRE¿ NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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Catalog Number 408394 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 whitacre¿ needle broke off into the patient during use.A tomography was used to identify the location of the needle fragment, and a separate procedure was needed to remove it.The following information was provided by the initial reporter, translated from (b)(6) to english: "when introducing the needle into the patient, the anesthesiologist felt a snap and when pulling it came the part of the needle and the bevel came out whole without bending.The tomography identified the artifact between the l3-l4 space, with depth to the epidural fat, not perforating the dura mater and not invading the spinal canal.The patient needed another procedure to remove the needle fragment.".
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Event Description
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It was reported that the bd whitacre¿ needle broke off into the patient during use.A tomography was used to identify the location of the needle fragment, and a separate procedure was needed to remove it.The following information was provided by the initial reporter, translated from portuguese to english: "when introducing the needle into the patient, the anesthesiologist felt a snap and when pulling it came the part of the needle and the bevel came out whole without bending.The tomography identified the artifact between the l3-l4 space, with depth to the epidural fat, not perforating the dura mater and not invading the spinal canal.The patient needed another procedure to remove the needle fragment.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/19/2021.H.6.Investigation: based on the sample provided to bd for evaluation, the reported condition was verified.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.According to the description of the complaint, the needle broke during use, there may have been a probable usability error may have occurred.H3 other text : see h.10.
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