Catalog Number 394601 |
Device Problems
Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).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 bd connecta plus3 white pegs could not be removed.The following information was provided by the initial reporter, translated from chinese to english: after connecting the three-way with the deep vein catheter, it could not be removed.
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of connection issues was not confirmed but component damage - no leak was confirmed upon inspection of the photo.The photo provided shows port damaged / broken into another device.Based off the damage observed in the photo the cause of the component damage is likely improper handling of the device or use of excessive force during device implementation.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.Bd cannot confirm the cause of the connection issues failure to our manufacturing process since no sample was returned for evaluation.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
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Event Description
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It was reported that the bd connecta plus3 white pegs could not be removed.The following information was provided by the initial reporter, translated from chinese to english: after connecting the three-way with the deep vein catheter, it could not be removed.
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Search Alerts/Recalls
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