BARD ACCESS SYSTEMS GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number 7857505 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 04/20/2018 |
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 rebu0097 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 when the red lumen of picc was flushed, the patient complained of pain and burning.Avas team was up to assess and they did not recommend cathflo at that time.The patient¿s arm circumference was measured and infusion was restarted, but stopped with alleged increase in arm size.Users decided not to use red lumen any longer at that time.It was stated a new picc was inserted with success and then old picc removed by avas team.Picc lumen was assessed and it was noted that there was a hole at the 35cm marking on the picc line and when the red lumen was flushed, saline would come out of the hole.White lumen flushed and no hole noted.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency 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 a leak was confirmed and the cause appears to be use related.The product returned for evaluation was one 5 fr dual lumen groshong nxt catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed in the red lumen, approximately 11.8 cm distal to the bifurcation.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The nursing procedure manual can be found online at www.Bardaccess.Com and provides the following guidance: ¿do not use a syringe smaller than 10ml to flush or confirm patency.Patency should be assessed with a 10ml or larger syringe with sterile saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the does.Do not infuse against resistance.Infusion pressures should never exceed 25 psi.Smaller syringes generate more pressure than larger syringes.¿ the nursing procedure manual also provides guidance for re-establishing catheter patency in the event the catheter becomes occluded or resistance is felt during flushing.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of rebu0097 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 when the red lumen of picc was flushed, the patient complained of pain and burning.Avas team was up to assess and they did not recommend cathflo at that time.The patient¿s arm circumference was measured and infusion was restarted, but stopped with alleged increase in arm size.Users decided not to use red lumen any longer at that time.It was stated a new picc was inserted with success and then old picc removed by avas team.Picc lumen was assessed and it was noted that there was a hole at the 35cm marking on the picc line and when the red lumen was flushed, saline would come out of the hole.White lumen flushed and no hole noted.
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Search Alerts/Recalls
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