MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F; PORT AND CATHETER ACCESSORIES

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.

• 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 Key: 16316288
• MDR Text Key: 309057717
• Report Number: 3006260740-2023-00357
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830406
• Number of Events Reported: 1
• 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 Number: 0601610
• Device Catalogue Number: 0601610
• Device Lot Number: REFX4541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: UNKNOWN
• Patient Sequence Number: 1