MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC SURECUFF; CHRONIC CATHETERS

Catalog Number	0600520
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Discolored (1170); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
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 return of the sample is pending.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
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the broviac cv catheter, single-lumen, 4.2f.During the catheter replacement procedure, it was allegedly the area from the thick end of the catheter to the narrowing step and insertion point was found to be dark red in patches.A bulge was noted within the catheter directly below the step.The catheter was removed.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the broviac cv catheter, single-lumen, 4.2f.During the catheter replacement procedure, it was allegedly the area from the thick end of the catheter to the narrowing step and insertion point was found to be dark red in patches.A bulge was noted within the catheter directly below the step.The catheter was removed.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 s/l catheter in two segments were returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.Blood residues were noted on the device.Discoloration was noted.Hydrostatic pressure was applied by clamping the distal end of the catheter.Upon infusion, the proximal portion of the strengthening sheath of the catheter was noted to be ballooned.A longitudinal split was made small amounts of water were noted exiting the split area.An additional longitudinal split was made, and split was found in the center portion of the inner tube within the clamping sleeve.The split were jagged edges, and surface could not be determined.Therefore, the investigation is confirmed for the reported discoloration, material protrusion and identified stretch and catheter burst.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4(unique identifier (udi) #), d6(b), 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 SURECUFF
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23423423
• Report Number: 3006260740-2025-08179
• Device Sequence Number: 8253567
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(11)240913(17)270328(10)HUJV0500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 0600520
• Device Lot Number: HUJV0500
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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 Sex: Unknown