Catalog Number 383323 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2022 |
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.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 saf-t-intima¿ iv catheter safety system was bent.The following information was provided by the initial reporter, translated from portuguese: "the catheter came bent.".
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Manufacturer Narrative
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Investigation summary: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of catheter kink / bent was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system was bent.The following information was provided by the initial reporter, translated from portuguese: "the catheter came bent.".
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Search Alerts/Recalls
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