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

Catalog Number	0600544
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will 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.H11: 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.
Event or Problem Description
It was reported that approximately two years post a chronic catheter placement, the catheter was allegedly exploded when flushed the line prior to infusion.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported catheter ballooning and catheter explosion during flushing as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (device, component, method).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
In (b)(6) 2018, a patient underwent a chronic catheter placement procedure.On (b)(6) 2020, it was reported that the catheter was allegedly exploded when flushed the line prior to infusion.It was further reported that catheter is ballooning near the hub of the catheter.Reportedly, the catheter was removed on (b)(6) 2020 and replaced.There was no reported patient injury.

• 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: 20875843
• Report Number: 3006260740-2024-07291
• Device Sequence Number: 15664432
• Product Code: LJS
• UDI-Device Identifier: 00801741051838
• UDI-Public: (01)00801741051838(17)250228(10)HUEQ0489
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 0600544
• Device Lot Number: HUEQ0489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/16/2026
• 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