C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CATHETER 5F BASIC TRAY DL W/MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Misassembled (1398)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
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 refv2001 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (refv2001) have been reported from the same facility in japan.
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Event Description
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It was reported that when the introducer needle was taken out of the case, the safety was locked.Therefore, the case was checked, there was no sheath in the case and the introducer needle with sheath did not have the sheath.Reportedly, another kit was used to complete the procedure.There was no reported patient involvement.It was reported this occurred with two devices.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.
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Event Description
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It was reported that when the introducer needle was taken out of the case, the safety was locked.Therefore, the case was checked, there was no sheath in the case and the introducer needle with sheath did not have the sheath.Reportedly, another kit was used to complete the procedure.There was no reported patient involvement.It was reported this occurred with two devices.This report addresses the second device.
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Search Alerts/Recalls
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