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	Difficult to Flush (1251); Fracture (1260); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a central venous catheter placement procedure using broviac cv catheter.On (b)(6), 2026, it was reported that the catheter fractured approximately two months after the device had been placed.It was also reported that the catheter could not be aspirated.As a result, the catheter was removed.There was no reported patient injury.
Event or Problem Description
A patient underwent a central venous catheter placement procedure using broviac cv catheter.On (b)(6) 2026, it was reported that the catheter fractured approximately two months after the device had been placed.It was also reported that the catheter could not be aspirated.As a result, the catheter was removed.There was no reported patient injury.
Event or Problem Description
A patient underwent a central venous catheter placement procedure using broviac cv catheter.On (b)(6) 2026, it was reported that the catheter fractured approximately two months after the device had been placed.It was also reported that the catheter could not be aspirated.As a result, the catheter was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H11: e1 (b)(6).D4: medical device expiration date: unknown, h4: device manufacture date: unknown.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is bard puerto rico.No new event information is being reported in this supplement.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.E1: (b)(6).D4: medical device expiration date: unknown, h4: device manufacture date: unknown.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: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 1 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is bard shannon limited.No new event information is being reported in this supplement.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.G1: 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, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50814278
• Report Number: 3006260740-2026-06813
• Device Sequence Number: 10152483
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/21/2026; 09/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/22/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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