Model Number 381112 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
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.
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Event Description
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It was reported that the bd angiocath¿ iv catheter was damaged.The following information was provided by the initial reporter: the catheter was damaged before use.
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Event Description
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It was reported that the bd angiocath¿ iv catheter was damaged.The following information was provided by the initial reporter: the catheter was damaged before use.
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Manufacturer Narrative
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H6: investigation summary bd received a 24 gauge angiocath device from lot 1181114 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 that the needle had pierced through the catheter tubing.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was likely a manufacturing defect caused by a misalignment between the needle and catheter during the catheter placement process.H3 other text : see h10.
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Search Alerts/Recalls
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