Model Number 381311 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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-n¿ iv catheters the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: during the preparation of the pkv, a defective plastic cannula was detected on 3 pvks.This is indicated by a slight change / thickening on the plastic cannula.If the needle is briefly withdrawn outside the patient and then carefully advanced again, the plastic cannula may be punctured with the needle in the area of the thickening.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-mar-2023.Investigation summary: our quality engineer inspected the 2 photos and 3 samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the sample photos and samples.Analysis of the sample photos showed that the needle of the device was through the catheter near the tip area.All 3 samples were examined.One sample had a ¿v¿ cut in the catheter tubing near the tip, one sample had the needle through the catheter near the tip and the final sample did not have any damages to the catheter.Bd was unable to determine a root cause for the reported defect since the samples with the catheter damages were returned in a used state.The ¿v¿ cut observed on one of the samples could be occur during product application or needle cover removal, but these root causes cannot be confirmed.There are currently controls in place during manufacturing that would automatically reject products with needle through catheter damages.Production records were reviewed, and this batch meets our manufacturing specification requirements.
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Event Description
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It was reported while using bd insyte-n¿ iv catheters the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: during the preparation of the pkv, a defective plastic cannula was detected on 3 pvks.This is indicated by a slight change / thickening on the plastic cannula.If the needle is briefly withdrawn outside the patient and then carefully advanced again, the plastic cannula may be punctured with the needle in the area of the thickening.
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Search Alerts/Recalls
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