Catalog Number 38831114 |
Device Problems
Material Puncture/Hole (1504); 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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Manufacturer Narrative
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Patient¿s birthday was not provided, (b)(6) 2019 was used based on age of patient 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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Event Description
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It was reported while using bd insyte¿ iv catheter 24ga the catheter tip was damaged.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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Event Description
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It was reported while using bd insyte¿ iv catheter 24ga the needle was through catheter while introducing the catheter.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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The following fields were updated due to additional information: b5: describe event or problem: it was reported while using bd insyte¿ iv catheter 24ga the needle was through catheter while introducing the catheter.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.H5:imdrf annex a grid: a041001.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, two (2) pictures were provided for evaluation by our quality engineer team.Through examination of the pictures, 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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Search Alerts/Recalls
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