C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM INTERMEDIATE KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of 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.The device has not been returned to the manufacturer for evaluation.H3 other text : device not received.
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Event Description
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It was reported, "the extension hose releases from the luer fitting/coupling." no other information was provided.It was reported this occurred with two devices.This report addresses the first device.
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Event Description
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It was reported, "the extension hose releases from the luer fitting/coupling." no other information was provided.It was reported this occurred with two devices.This report addresses the first device.Additional information received: there was no patient impact.No exposure to blood or bodily fluids.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of 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.The complaint of a broken extension set is confirmed; however, the exact cause is unknown.One photograph of an extension set was returned for evaluation.An initial visual observation of the photograph showed an extension set attached to a powerglide pro catheter.The distal luer hub of the extension set was observed to be completely separated from the tubing of the extension set.Use residue was observed on the sample in the returned photograph.While the tubing of the extension set was observed to be detached from the luer hub, no details of the fracture sites could be discerned from the returned photograph.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
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Search Alerts/Recalls
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