Catalog Number 381311 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2022 |
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 while using bd insyte-n¿ peripheral venous catheter the tip of the catheter was found to be defective.There was no report of patient impact.The following information was provided by the initial reporter: at the time of inserting the nurse took the dm out of its packaging.At the time of pricking, impossible to pierce the skin of the child.Looking more closely, she realizes that the catheter is defective at its distal end (entry point).
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Event Description
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It was reported while using bd insyte-n¿ peripheral venous catheter the tip of the catheter was found to be defective.There was no report of patient impact.The following information was provided by the initial reporter: at the time of inserting the nurse took the dm out of its packaging.At the time of pricking, impossible to pierce the skin of the child.Looking more closely, she realizes that the catheter is defective at its distal end (entry point).
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-apr-2022.H.6.Investigation: one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection.A ¿v-cut¿ was observed near the catheter tip.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.From the returned sample, a ¿v-cut¿ was observed on the catheter that matches the bevel shape, which could be caused by the needle piercing through the catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the inline tip spear vision inspection system.Needle pierced through catheter could also happen during product application when the product was manipulated.As the sample was returned in open packaging, the actual root cause could not be established.
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Search Alerts/Recalls
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