MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS

Catalog Number	0600120
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Flush (1251); Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a chronic catheter placement procedure using the broviac cv catheter.28 days post procedure on (b)(6) 2025, it was noted that the flushing was not smooth, and after removing using surgery, it was found that the tube was ruptured.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be 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.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
A patient underwent a chronic catheter placement procedure using the broviac cv catheter.The product was placed in the patient's body.After 28 days post the procedure, it was noted that the flushing was not smooth, and after removing it using surgery, it was found that the tube was ruptured.Additionally, only one hole was noted.There were no reported patient injuries.
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.B5, d4 (medical device lot #, medical device expiration date, unique identifier (udi) #), g3, h6 (device, 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.
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: one s/l catheter was returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.A s-shaped split was noted on the catheter body on the distal end.No other catheter segment was returned.The edges of the s-shaped split were noted to be uneven, and surface was noted to be granular in both regions.Upon infusion, a leak from the s-shaped split was noted.Aspiration was attempted and was unsuccessful.Flushing issue was due to catheter fracture and aspiration were failed during functional testing.Therefore, the investigation is confirmed for the reported fracture and flushing difficulty.However, the investigation is unconfirmed for the reported material hole as no hole were noted during sample evaluation.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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
A patient underwent a chronic catheter placement procedure using the broviac cv catheter.The product was placed in the patient's body.After 28 days post the procedure, it was noted that the flushing was not smooth, and after removing it using surgery, it was found that the tube was ruptured.Additionally, only one hole was noted.There were no reported patient injuries.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
• 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: 23377311
• Report Number: 3006260740-2025-07999
• Device Sequence Number: 8899789
• Product Code: LJS
• UDI-Device Identifier: 00801741051715
• UDI-Public: (01)00801741051715(17)270628(10)HUGT2030
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 0600120
• Device Lot Number: HUGT2030
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 12/30/2025; 05/07/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025; 01/02/2026; 05/11/2026
• 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