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	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Expulsion (2933); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent placement of a hickman/leonard/broviac central venous catheter in the left internal jugular vein for the administration of chemotherapy to treat leukemia.Following the procedure, on (b)(6) 2026, it was discovered that the broviac catheter had completely fractured.Prior to the fracture, the catheter had reportedly become twisted on multiple occasions due to patient movement in bed and had been subjected to tension while the patient was crawling; therefore, wear and tear associated with these factors was considered a possible contributing cause of the fracture.It was further reported that the catheter cuff was exposed outside the body, suggesting that it had become dislodged.The patient's current condition was unknown.
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f: the information provided by bd represents all of 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: 50446950
• Report Number: 3006260740-2026-06179
• Device Sequence Number: 10376883
• 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
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0600520
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown