BARD ACCESS SYSTEMS GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Catalog Number 7617405J |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw1364 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that the connector and lock sleeve were connected by applying stronger force than usual because they were too tight; as a result, blood backflow was not confirmed and flushing failed, so the device was exchanged for another.The catheter connector, the lock sleeve and a part of the catheter to be returned.There was no reported patient injury.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an occluded catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong catheter.Usage residues were observed on the sample.The sample was received assembled with a two-piece connector.The catheter terminated approximately 10cm distal of the two-piece connector.The catheter appeared bunched where it exited from the connector.A gap was evident between the two segments of the connector.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded.Following longitudinal bisection of the distal connector segment, inspection of the catheter confirmed that it was bunched and folded within the bore.The compression sleeve was advanced nearly halfway into the narrow region of the bore.Microscopic inspection of the sample confirmed that the catheter was bunched and folded within the bore and that the compression sleeve was over-advanced.The crumpled and folded state of the catheter and the position of the compression sleeve were consistent with attempting connector assembly over a bunched and compressed catheter.Such catheter bunching occurs if the catheter is advanced too far onto the connector cannula prior to assembly.The product ifu states ¿gently advance the catheter onto the connector blunt until it butts up against the colored plastic body.The catheter should lie flat on the blunt without any kinks.¿ a lot history review (lhr) of rebw1364 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that the connector and lock sleeve were connected by applying stronger force than usual because they were too tight; as a result, blood backflow was not confirmed and flushing failed, so the device was exchanged for another.The catheter connector, the lock sleeve and a part of the catheter to be returned.There was no reported patient injury.
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