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	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a catheter placement procedure using hickman single lumen catheter for the purpose of administering nutrition.It was reported that the area around the junction between the thin and thick parts of the catheter expanded during drug solution was administered.Furthermore, the leak was noted and appears to be internal, the device was replaced with another device.
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 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 catheter placement procedure using hickman single lumen catheter for the purpose of administering nutrition.It was reported that the area around the junction between the thin and thick parts of the catheter expanded during drug solution was administered.Furthermore, the leak was noted and appears to be internal, the device was replaced with another device.Current status of patient is unknown.
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: one s/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.Upon infusion, ballooning was observed on the catheter body, proximal to the distal end of the clamping sleeve.A longitudinal split was made throughout the catheter where the ballooning was observed for further investigation.Upon split created, small amounts of water were observed exiting the split sight.What appeared to be thrombus, was observed exiting the distal end of the catheter.Upon infusion, a leak was observed running down the inside of the clamping sleeve and inner lumen.Further observation was performed until reaching between the catheter hub and clamping sleeve.Another infusion test was performed, and a leak was observed from what appeared to be a burst on the proximal portion of the inner lumen, proximal to the luer and a split in the center portion of the inner lumen.Therefore, the investigation is confirmed for the reported catheter stretched, fluid leak and material protrusion /extrusion issues and identified catheter burst issues.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 (device, method, result, conclusion).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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22724035
• Report Number: 3006260740-2025-05577
• Device Sequence Number: 15558096
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(17)270328(10)HUJV0500
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0600520
• Device Lot Number: HUJV0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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