MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F; CHRONIC CATHETERS

Catalog Number	0600520
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Stretched (1601); Material Protrusion/Extrusion (2979); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a central venous catheter placement procedure, the outer layer of the larger caliber section near the clamp allegedly found with bubble formation.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records could not be performed.The device has not returned to the manufacturer for evaluation.However, photo was added.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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: two s/l repair catheters were returned for sample evaluation.Along with return sample two video was provided for review.Gross, visual, microscopic visual, tactile and functional evaluations were performed.In sample one upon infusion, leak and ballooning was noted on the center portion of the clamping sleeve while water was exiting the distal end of the catheter.A longitudinal split was made on the clamping sleeve where the ballooning was observed for further investigation.Upon split created, small amounts of water were observed exiting the split area.An infusion test was performed once again, and small leaks were observed exiting the split.A longitudinal split was further created until reaching the luer.The split clamping sleeve was inspected, and the inner lumen was found to have a complete circumferential break with jagged edges and a granular surface.In sample two upon infusion, ballooning was noted on the center portion of the clamping sleeve while water was exiting the distal end of the catheter.Further evaluation was performed on the catheter area where ballooning was noted.Hydrostatic pressure was applied.Upon infusion, ballooning was noted on the center portion of the clamping sleeve.Longitudinal split was made to the clamping sleeve where the ballooning was noted for further investigation.The split clamping sleeve was inspected, and the inner lumen was found to have a complete circumferential break with jagged edges and a granular surface on the proximal end.Also split was noted proximal to the distal end of the tissue cuff.Ballooning was noted in video review for two both the devices.Liquid bubble formation on the catheter was due to minute spilt in both the catheter.Therefore, the investigation is confirmed for the reported air and gas issue and identified, fracture, material separation, fluid leak, stretch and material protrusion issues for both the devices.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.B5, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using broviac cv catheter, single-lumen, 4.2f.During the procedure, the outer layer of the larger caliber section near the clamp was allegedly found bubble formation.There were no reported patient injury.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F
• 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: 23308148
• Report Number: 3006260740-2025-07814
• Device Sequence Number: 14688049
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(17)261128(10)HUHS1421
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830256
• 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): 12/30/2025

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: HUHS1421
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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