Model Number 381123 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2022 |
Event Type
malfunction
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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 when that before use of the bd angiocath¿ iv catheter the needle and the catheter were separated from the hub and trapped inside the needle cover.The following information was provided by the initial reporter.When the hcp removed the protection needle cover before use, the needle and the catheter were separated from the hub and trapped inside the needle cover.¿.
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Event Description
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It was reported when that before use of the bd angiocath¿ iv catheter the needle and the catheter were separated from the hub and trapped inside the needle cover.The following information was provided by the initial reporter.When the hcp removed the protection needle cover before use, the needle and the catheter were separated from the hub and trapped inside the needle cover.¿.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 23-jun-2022.H.6.Investigation summary: bd received a 22 gauge angiocath device from lot 1168743 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 unit and observed no visible defects with the returned sample.The needle cover was removed as it was reported that the catheter was stuck inside.Upon removal of the needle cover the catheter was found to still be attached to the needle and not separated/stuck in the needle cover.Therefore, based off the visual inspection the engineer was unable to verify the reported defect.Since no defects could be identified a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.
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Search Alerts/Recalls
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