C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
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Model Number N/A |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
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 : device not returned for evaluation.
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Event Description
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It was reported by the customer "placement of the midline catheter for which the mandrel (usually already in place in the catheter with a three-way connector and a "swollen" proximal end) is absent - many changes of brands and models due to supply difficulties.The catheter is inserted using the classic technique through a peelable introducer.The catheter was rinsed.The next day, injection difficulties persisted after rinsing.At d2 or d3 the catheter was removed: discovery of a mandrel inside the catheter, being expelled by the distal end.Significant risk of intravascular metallic foreign body.Current patient status: no consequences except for loss of venous line.Actions taken in the health care institution for the management of the patient: withdrawal of the medical device, observation of the defect.No particular measure.
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Search Alerts/Recalls
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