Catalog Number 4251644-020 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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As reported by the user facility: it was reported that the introcan safety pur 20g, 1.1x32mm-us while being used on a patient were "bendy" during insertion on patient and shattered during use.The emergency department has reported that the 20-gauge introscan safety iv catheter lot number 0061864777 has been kinking in patients during the catheter insertion and occasionally shredding when pulling the needle out of the catheter.No injury reported.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number: (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).Fifty-nine (59) unused samples were provided for investigation.The provided 59 samples were visually evaluated, and no product deviation was noted.The defect is not confirmed.Retained units were evaluated and passed the internal testing.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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