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	Difficult to Flush (1251); Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
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 return of the sample is pending.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.
Event or Problem Description
A patient underwent a chronic catheter placement procedure using the hickman/leonard/broviac central venous catheter.On (b)(6) 2025, post the procedure clogs was noted within 02 to 03 weeks with epo-plastinol.Additionally, there was an issue with flushing and aspiration.Catheter was removed.There was no reported patient injury.
Event or Problem Description
A patient underwent a chronic catheter placement procedure using broviac central venous catheter.On (b)(6) 2025, post the procedure clogs was noted within 02 to 03 weeks with epo plastinol.Additionally, there was an issue with flushing and aspiration.The catheter was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one broviac s/l catheter was received for evaluation.The distal catheter segment was not returned.Visual, microscopic, tactile and functional evaluation were performed.The complaint sample was returned with the clamp disengaged.The tissue cuff was intact and had residue throughout.The catheter was patent to both infusion and aspiration without issue.No leaks were observed.However, the investigation is inconclusive for obstruction of flow, difficult to flush and suction issue as the sample evaluation results indicating no flow issues under laboratory conditions may not be representative of the condition of the device during use and distal catheter segment was not returned.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method, result, conclusion).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.

• 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: 24018429
• Report Number: 3006260740-2025-10344
• Device Sequence Number: 21129946
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• UDI-Public: (01)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 Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/04/2026
• 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