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); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
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 was performed.The return of the sample is pending.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 chronic catheter placement procedure using the broviac catheter.On (b)(6) 2025, post the procedure the line gets twisted in a certain spot repeatedly resulting in a cracked line.It was also noted that saline was coming from a crack in the line just above the reinforced clamping area.A portion of the original line still remained in the patient, but it was not a part that broke this time.Patient brought into the ed to repair the line.There was no reported patient injury.
Event or Problem Description
A patient underwent a chronic catheter placement procedure using the broviac catheter.On (b)(6) 2025, post the procedure the line gets twisted in a certain spot repeatedly resulting in a cracked line.It was also noted that saline was coming from a crack in the line just above the reinforced clamping area.A portion of the original line still remained in the patient, but it was not a part that broke this time.Patient brought into the ed to repair the line.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.As per reported event patient frequently moves and rolls around, resulted in a cracked, deformation and leaking issue.As per procedure catheter securement using dressing suggested to avoid rolling ad deformation which can lead to line fracture.Therefore, the investigation is confirmed for the identified improper procedure.However, the investigation is inconclusive for the reported crack, leak and deformation issues as no objective evidence was provided for review.The root cause for improper procedure is determined to be using related however patient factor as that time could determine based one available information.The definitive root cause could not be determined for device problem based upon available information.Labelling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instruction for use states: secure catheter at exit site with a sterile dressing.The external segment of the catheter should be coiled and taped.Avoid tension on the catheter segment to prevent dislodging the catheter.Coil the catheter, check to see that it is not kinked or pinched, and secure it to the chest or dressing with tape.This will prevent pulling of the catheter at the exit site and decrease irritation.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: 23678474
• Report Number: 3006260740-2025-09145
• Device Sequence Number: 13332859
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(11)230622(17)261128(10)HUHS1413
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/06/2026

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: HUHS1413
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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: 3 YR
• Patient Sex: Unknown