Catalog Number 381923 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to the customer's report, the catheter was separated from the catheter hub.".
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Manufacturer Narrative
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The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-12-21.Investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one retracted needle assembly, one blue adapter, and one catheter wedge assembly.During the visual examination, it was identified that the wedge and catheter have backed out of the blue adapter which is considered a catheter wedge backout.The reported defect was confirmed.A microscopic inspection of the blue adapter was performed to identify if swage marks were present.Microscopic inspection revealed that no swage marks are present indicating that an improper swage occurred.This defect has been linked to the manufacturing process and corrective actions have been initiated to address the issue.A 100% vision section is in place to detect short flare or incorrect swage depth.Additionally, operators perform sampling per quality procedures for catheter pull tests and retraction.Preventative maintenance is also performed to ensure proper function and upkeep of the equipment.A device history record review could not be performed as the lot number is unknown.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the catheter was separated from the catheter hub.".
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Search Alerts/Recalls
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