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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED); CATHETER, HEMODIALYSIS, NON-IMPLANTED

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C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED); CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 04/30/2022
Event Type  malfunction  
Event Description
It was reported the patient was admitted to the hospital due to abdominal pain for 10 hours.In order to carry out blood purification treatment smoothly, femoral vein puncture was performed at 21:30 on (b)(6) 2022.During the operation, the guide wire was bent in many places, resulting in the failure of the dialysis catheter to penetrate the femoral vein smoothly.
 
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex2166 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED)
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14518729
MDR Text Key292792685
Report Number3006260740-2022-01976
Device Sequence Number1
Product Code MPB
UDI-Device Identifier00801741045608
UDI-Public(01)00801741045608
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K090102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2022
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 Number5594150
Device Lot NumberREEX2166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2022
Initial Date FDA Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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