Model Number 309620 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while using bd¿ catheter tip syringe sterile the device was deformed and noticed after use.There was no report of patient impact.The following information was provided by the initial reporter: material no: 309620 batch no: 1215275 it was reported that catheters are very stiff and not lasting a day.
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Manufacturer Narrative
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 309620 and lot number 1215275.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
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Event Description
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It was reported while using bd¿ catheter tip syringe sterile the device was deformed and noticed after use.There was no report of patient impact.The following information was provided by the initial reporter: material no: 309620, batch no: 1215275.It was reported that catheters are very stiff and not lasting a day.
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Search Alerts/Recalls
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