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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS
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C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS Back to Search Results
Model Number 0600100
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/18/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2024).
 
Event or Problem Description
It was reported that approximately six month post catheter placement, the catheter allegedly had a hole in the thick part and fluid leaked.There was no reported patient injury.
 
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Brand Name
BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
Common Device Name
CHRONIC CATHETERS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11259040
Report Number3006260740-2021-00171
Device Sequence Number3996517
Product Code LJS
UDI-Device Identifier00801741051708
UDI-Public(01)00801741051708
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K830256
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/11/2021
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
Operator of Device Health Professional
Device Model Number0600100
Device Catalogue Number0600100
Device Lot NumberHUDR1825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/05/2021
Initial Report FDA Received Date02/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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