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Model Number FEM10120 |
Device Problems
Positioning Failure (1158); Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a stent graft placement procedure in the left cephalic arch via left upper arm fistula, physician allegedly felt lot of pressure to deploy the device.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Event Description
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It was reported that during a stent graft placement procedure in the left cephalic arch via left upper arm fistula, physician allegedly felt lot of pressure to deploy the device.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 03/2026), g3.H11: h6 (device).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Search Alerts/Recalls
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