Catalog Number 38831114 |
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 03/20/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd insyte¿ iv catheter 24ga the needle pierced the catheter.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: when opening the medical device, it is observed that it is with damaged point.
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Manufacturer Narrative
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A.2.Patient¿s birthday was not provided, (b)(6) 2022 was used based on age of patient.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary: a device history record review was completed for provided material number 38831114 and lot number 2053926.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture was provided for evaluation by our quality engineer team.Through examination of the picture, the needle was observed through the catheter.It is possible that this incident resulted from an improper adjustment in the manufacturing station which led to improper fittings for the catheter length.It is also possible that the vision system in place was not properly configured.
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Event Description
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It was reported while using bd insyte¿ iv catheter 24ga the needle pierced the catheter.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: when opening the medical device, it is observed that it is with damaged point.
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Search Alerts/Recalls
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