Catalog Number 384021 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that bd introducer introsyte-n 1.9f 1.9cm catheter was defective/damaged the following information was provided by the initial reporter; it was reported by customer that " after picc insertion through an introducer, i attempted to "peel" the introducer back to remove it off of the picc catheter and one side stuck to the catheter causing difficulty removing the remaining introducer fragments off the picc catheter potentially causing damage to the picc catheter" verbatim from the customer: " after picc insertion through an introducer, i attempted to "peel" the introducer back to remove it off of the picc catheter and one side stuck to the catheter causing difficulty removing the remaining introducer fragments off the picc catheter potentially causing damage to the picc catheter".
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Manufacturer Narrative
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Our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection and testing of the sample.Analysis of the sample showed that the catheter had broken in two.Bd determined that the cause of the failure could be related to our tip forming process.A retraining has been performed with all manufacturing personnel involved in the tip forming process, to prevent the reoccurrence of this failure mode.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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
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Event Description
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No additional information provided.
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Search Alerts/Recalls
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