Catalog Number 38831114 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
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 catheter tip was damaged on the bd insyte 24ga x 0.75in.The following information was provided by the initial reporter, translated from spanish to english: at the moment of puncturing the patient, it was felt a difficult to insert the catheter, and when it was removed it was observed that the catheter tip is damaged.
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Manufacturer Narrative
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H6: investigation summary; a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 9284824, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the catheter tip was bent.Based off the provided photo the engineer was able to verify the reported defect.However, during follow up attempts it was determined that the tip adhesion was not being broken prior to insertion and was likely the cause of the bent tip.H3 other text : see h10.
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Event Description
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It was reported that the catheter tip was damaged on the bd insyte 24ga x 0.75in.The following information was provided by the initial reporter, translated from spanish to english: at the moment of puncturing the patient, it was felt a difficult to insert the catheter, and when it was removed it was observed that the catheter tip is damaged.
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Search Alerts/Recalls
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