C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Gas/Air Leak (2946); Pressure Problem (3012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds2479 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reds2479) have been reported from the same facility in (b)6).
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Event Description
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It was reported that performed puncture in this patient.After the introducer needle was attached to syringe, no pressure was felt during aspiration.When performing aspiration, bubbles and fluid leaks were noted at the hub.Immediately replaced with another dialysis catheter, and also no pressure was felt, bubbles and fluid leak still occurred.Replaced with a third dialysis catheter.And the problem was addressed, with no abnormality.This report addresses the second device.
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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 returned for evaluation.
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Event Description
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It was reported that performed puncture in this patient.After the introducer needle was attached to syringe, no pressure was felt during aspiration.When performing aspiration, bubbles and fluid leaks were noted at the hub.Immediately replaced with another dialysis catheter, and also no pressure was felt, bubbles and fluid leak still occurred.Replaced with a third dialysis catheter.And the problem was addressed, with no abnormality.This report addresses the second device.
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Search Alerts/Recalls
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