Catalog Number 382523 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd insyte¿ autoguard¿ bc shielded iv catheter broke.The following information was provided by the initial reporter: "after entering the vein and seeing a flash, when we went to advance the catheter, it would bend at the insertion site breaking the catheter.This happened multiple times.I have been using these for 2 years and this has never happened.".
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Manufacturer Narrative
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H6: investigation summary: bd received five sealed 22 gauge insyte autoguard blood control units from lot 2305381 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical damage or deformities.There were no visible bends or breaks found to the catheters.Next, the units were tested for functionality.The engineer attempted to puncture a latex tub to simulate venipuncture and catheter advancement.No bending or breaking was observed during testing and the units were found to be functioning as intended.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during investigation a definitive root cause could not be determined.
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Event Description
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It was reported that 3 bd insyte¿ autoguard¿ bc shielded iv catheter broke.The following information was provided by the initial reporter: "after entering the vein and seeing a flash, when we went to advance the catheter, it would bend at the insertion site breaking the catheter.This happened multiple times.I have been using these for 2 years and this has never happened.".
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Search Alerts/Recalls
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