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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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 first device.
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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 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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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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a prematurely activated safety mechanism is inconclusive due to the state of the returned sample.Two 5 fr dual lumen groshong nxt catheter kits were returned for evaluation.An initial visual observation showed both kits were returned open.One kit was found to contain all of the kit components except the introducer needle, and the other kit was found to only contain an introducer needle.The safety mechanism of this introducer needle was found to be activated and engaged over the needle tip.The needle guard was returned, but the cylinder of the safety mechanism was not returned.No obvious evidence of use was observed on the introducer needle.While the safety mechanism of the returned introducer needle was found to be activated, the opened state of the packaging made it difficult to determine when or where the safety mechanism was activated.Therefore, this complaint is inconclusive.H3 other text : evaluation findings are in section h.11.
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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 first device.
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