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

Catalog Number	0601610
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
A patient underwent a repair kit placement procedure.On (b)(6) 2025, a crack was noted on repair line.There was no reported patient injury.
Event or Problem Description
A patient underwent a repair kit placement procedure using the hickman repair kit.On (b)(6) 2025, the crack was noted on repair line.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one hickman s/l repair kit catheter was received for evaluation, and one photo was provided for review.The photo shows the product details mentioned on the package which are matched with tw details.Visual, microscopic, tactile and functional evaluation were performed.A cap was noted on the luer.The complaint sample was returned with the clamp engaged.A longitudinal split was noted on the catheter body, proximal to the adhesive on the distal end of the clamping sleeve in which edges were uneven and surface noted to be smooth with residue throughout.Therefore, the investigation is confirmed for the identified burst issue and unconfirmed for the reported fracture issue as more specific burst code was identified.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion).Section a through f: the information provide by bd represents all 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.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F
• Common Device Name: 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: 23678597
• Report Number: 3006260740-2025-09150
• Device Sequence Number: 8901501
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385(11)241022(17)270831(10)REJX1025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: 0601610
• Device Lot Number: REJX1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Unknown