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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 REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F; PORT AND CATHETER ACCESSORIES

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C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F; PORT AND CATHETER ACCESSORIES Back to Search Results
Model Number 0601610
Device Problems Coagulation in Device or Device Ingredient (1096); Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2023
Event Type  malfunction  
Event Description
It was reported that during preparation of a catheter repair procedure, the glue was allegedly hardened.There was no patient contact.
 
Manufacturer Narrative
A voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.As the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiration date: 09/2023.Device not returned.
 
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Brand Name
BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F
Type of Device
PORT AND CATHETER ACCESSORIES
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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key16316288
MDR Text Key309057717
Report Number3006260740-2023-00357
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741036385
UDI-Public(01)00801741036385
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K830406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 01/18/2023
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 Number0601610
Device Catalogue Number0601610
Device Lot NumberREFX4541
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2023
Initial Date FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberUNKNOWN
Patient Sequence Number1
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