MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Broviac CV Catheter, Single-Lumen, 6.6F; Chronic Catheters

Catalog Number	0600540
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, a patient underwent a chronic catheter placement procedure using the broviac central venous catheter.On (b)(6) 2026, there was a pinhole noted and it caused a fluid leak.The catheter was removed on the same day.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2018, a patient underwent a chronic catheter placement procedure using a hickman/leonard/broviac central venous catheter.On (b)(6) 2026, a pinhole was noted near the catheter hub, which caused a fluid leak.The catheter was repaired using a repair kit.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 is currently being 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one s/l broviac catheter loaded into a syringe was received for sample evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The complaint sample appeared to have residue.The catheter hub was noted to have a small crack.Upon infusion, what appeared to be a leak, was observed from the catheter hub.Therefore, the investigation is confirmed for reported fluid leak and identified fracture issue.However, the investigation is unconfirmed for reported material puncture or hole issue as more appropriate fracture code has been identiifed.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.B5, e1, g3, h6 (device, component, method, result, conclusion) 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, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50191458
• Report Number: 3006260740-2026-05596
• Device Sequence Number: 20357897
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• 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: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 0600540
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/21/2026
• 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