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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FLEXXICON LL KIT 12F X 20CM (SHORT-TERM, DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED
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BARD ACCESS SYSTEMS FLEXXICON LL KIT 12F X 20CM (SHORT-TERM, DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number N/A
Device Problem Backflow (1064)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported that the catheter was filled with heparin saline solution.However, backflow of blood into the catheter occurred and color of the liquid in the extension tube changed from colorless to red.It was stated there was no leak from the catheter.There was no reported patient injury.
 
Manufacturer Narrative
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, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a backflow of blood into the catheter was inconclusive due to the sample condition.One flexxicon ii dialysis catheter was returned for investigation.The catheter exhibited evidence of use.The catheter was received with the clamps closed over each extension leg.What appeared to be dry blood residue was observed in the extension legs distal to the closed clamps.The bifurcation was discolored, and a tacky residue was observed on the rotatable suture wings.A functional test revealed that both lumens were patent to infusion, but the venous lumen was sluggish to infuse and aspirate due to the residue within the lumen.The residue could not be flushed from the lumens during testing.The clamps were closed and an attempt was made to flush and aspirate past the clamps, but no fluid could be flushed or aspirated past the closed clamps.The complaint is inconclusive since the reported event could not be reproduced and since other contributing factors, such as pressure gradient and technique during use, were unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the catheter was filled with heparin saline solution.However, backflow of blood into the catheter occurred and color of the liquid in the extension tube changed from colorless to red.It was stated there was no leak from the catheter.There was no reported patient injury.
 
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Brand Name
FLEXXICON LL KIT 12F X 20CM (SHORT-TERM, DUAL-LUMEN)
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9857033
MDR Text Key194528157
Report Number3006260740-2020-00909
Device Sequence Number1
Product Code MPB
UDI-Device Identifier00801741045530
UDI-Public(01)00801741045530
Combination Product (y/n)N
PMA/PMN Number
801(E)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number5577220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Event Location Hospital
Initial Date Manufacturer Received 02/28/2020
Initial Date FDA Received03/19/2020
Supplement Dates Manufacturer Received04/07/2020
Supplement Dates FDA Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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