C.R. BARD, INC. (BASD) -3006260740; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2022 |
Event Type
malfunction
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Event Description
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It was reported the samples taken on picc line have come back erroneous.No other information was provided.
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Manufacturer Narrative
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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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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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 initial complaint was reported as a bd manufactured product.Upon receipt of sample, the product was found to not be manufactured by bd.
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Event Description
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It was reported the samples taken on picc line have come back erroneous.No other information was provided.
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Search Alerts/Recalls
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