Catalog Number 381212 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
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 needle pierced through the bd insyte¿ iv catheter while introducing it.The following information was provided by the initial reporter: "insyte 24 kinking received testimony from the customer there are kinking during use insyte 24 insertion".
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of catheter kink / bent was not confirmed but needle through catheter was observed upon inspection of the photos.Analysis of one of the sample photos showed that catheter bent was not observed.Instead, it was observed that the needle pierced through the catheter near the adapter nose with the adapter being moved halfway from the needle hub.The blood in the catheter and needle flashback chamber indicated the product was used.The second photo showed the catheter adapter without the cannula and needle hub.The image was also too blurry to determine catheter bent defect.The root cause of the failure could not be determined since the sample in the photos is used.Needle pierced through catheter could happen when the product was manipulated during product insertion, but we cannot confirm how the product was used.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
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Event Description
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It was reported that the needle pierced through the bd insyte¿ iv catheter while introducing it.The following information was provided by the initial reporter: "insyte 24 kinking received testimoni from the customer there are kinking during use insyte 24 insertion".
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Search Alerts/Recalls
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