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	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
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 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.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.
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound-guided catheter placement procedure in the right subclavian vein using a hickman/leonard/broviac central venous catheter.During medication administration on (b)(6) 2026, leakage of heparin solution was observed due to damage at the transition from the clamp area to the narrow segment.On the proximal side of the large-diameter to small-diameter transition (approximately 30 mm), a v-shaped split was present, and a partial (non-complete) break of about 3 mm was observed at the bend of the v-shaped split.Reportedly, the outer layer showed a complete tear, while a small tear of approximately 2 mm was identified in the inner layer at the same site.Furthermore, the damaged catheter was repaired using a repair kit.There were no reported patient injuries.
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound-guided catheter placement procedure in the right subclavian vein using a hickman/leonard/broviac central venous catheter.During medication administration on (b)(6) 2026, leakage of heparin solution was observed due to damage at the transition from the clamp area to the narrow segment.On the proximal side of the large-diameter to small-diameter transition (approximately 30 mm), a v-shaped split was present, and a partial (non-complete) break of about 3 mm was observed at the bend of the v-shaped split.Reportedly, the outer layer showed a complete tear, while a small tear of approximately 2 mm was identified in the inner layer at the same site.Furthermore, the damaged catheter was repaired using a repair kit.There were no reported patient injuries.
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.The investigation is inconclusive for the reported fracture, separation and leak issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: the reported material information is for disposable (single use) device and therefore a service history review is not applicable.G3, h6 (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, 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: 24453884
• Report Number: 3006260740-2026-01212
• Device Sequence Number: 10148025
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(17)270328(10)HUJQ2155
• 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,Followup
• Report Date (Section B): 03/16/2026

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: 0600520
• Device Lot Number: HUJQ2155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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 Age: 7 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG