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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED
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BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds2381 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the patient was hospitalized for decompensated liver cirrhosis and hepatic encephalopathy at 11:42:02, (b)(6) 2019, with lethargy and the blood urea of 123ug/dl by a test performed after hospitalization.At 19:35, crrt treatment was administered at the bedside (access point: femoral vein).At 06:40, (b)(6), a patient whose bed was next to this patient found bleeding from the thigh of this patient, who immediately pressed the site.A nurse found the external portion of the dialysis catheter was broken, and immediately took hemostasis measures.The physician removed the catheter.
 
Event Description
It was reported that the patient was hospitalized for decompensated liver cirrhosis and hepatic encephalopathy at 11:42:02, (b)(6) 2019, with lethargy and the blood urea of 123ug/dl by a test performed after hospitalization.At 19:35, crrt treatment was administered at the bedside (access point: femoral vein).At 06:40, (b)(6), a patient whose bed was next to this patient found bleeding from the thigh of this patient, who immediately pressed the site.A nurse found the external portion of the dialysis catheter was broken, and immediately took hemostasis measures.The physician removed the catheter.
 
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter was confirmed, and the cause appears to be use related.The product returned for evaluation was one 20 cm niagara catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as scissors or a scalpel.The returned product sample was evaluated and a break was observed just distal to the molded joint.Microscopic examination of the catheter break confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of reds2381 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
NIAGARA DIALYSIS CATHETER KIT 13.5F 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 Key9495654
MDR Text Key176461327
Report Number3006260740-2019-03933
Device Sequence Number1
Product Code MPB
UDI-Device Identifier00801741045578
UDI-Public(01)00801741045578
Combination Product (y/n)N
PMA/PMN Number
K030268
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 02/10/2020
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 Number5593200
Device Lot NumberREDS2381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2019
Event Location Hospital
Initial Date Manufacturer Received 11/28/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received01/27/2020
Supplement Dates FDA Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
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