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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number N/A
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2023
Event Type  malfunction  
Event Description
It was reported that when conducting the incoming inspection, the hospital found hairs in the catheter (5553200).
 
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 manufacturer has received the sample and will evaluate.Results are expected soon.
 
Event Description
It was reported that when conducting the incoming inspection, the hospital found hairs in the catheter (5553200).
 
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.Based on a review of this information, the following was concluded: the complaint of a foreign material is confirmed and was determined to be manufacturing related.One 12 fr niagara slim-cath acute dialysis catheter kit was returned for evaluation.An initial visual observation showed the kit was returned sealed.A hair was observed within the kit packaging near the bottom of the kit.The investigation was forwarded to the end-item manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.The manufacturing site has provided awareness training for this issue to all personnel involved in this operation.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
 
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Brand Name
NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT DL
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17684048
MDR Text Key322649951
Report Number3006260740-2023-03908
Device Sequence Number1
Product Code MPB
UDI-Device Identifier00801741045363
UDI-Public(01)00801741045363
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K010778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/30/2023
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 Number5553200
Device Lot NumberREGQ3872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2023
Initial Date FDA Received09/05/2023
Supplement Dates Manufacturer Received11/29/2023
Supplement Dates FDA Received12/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2022
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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