MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F; CHRONIC CATHETERS

Catalog Number	0606560
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the sample was not returned for evaluation, one video was provided and reviewed.The video shows the partial view of catheter.The physician was infusing the solution to white luer extension leg of the catheter using the syringe.Upon infusion, ballooning was noted on the white luer extension leg near the joint.Therefore, the investigation is confirmed for the identified material protrusion and stretched issue.However, the investigation is unconfirmed for the reported bubble issue as more appropriate stretch and protrusion were identified based on video review.The definitive root cause could not be determined based upon available 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, component, method, result).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
On (b)(6) 2025, a 53-year-old female patient underwent a central venous catheter placement procedure using the hickman/leonard/broviac central venous catheter.Post the procedure, it was noted that the device showed a bubble.The catheter was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for 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 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
On (b)(6) 2025, a patient underwent a central venous catheter placement procedure using hickman/leonard/broviac central venous catheter.Post the procedure, it was noted that the device showed a bubble.The catheter was removed.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F
• 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: 24386180
• Report Number: 3006260740-2026-00975
• Device Sequence Number: 21378713
• Product Code: LJS
• UDI-Device Identifier: 00801741052019
• UDI-Public: (01)00801741052019(11)250522(17)290828(10)HUKR1370
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 0606560
• Device Lot Number: HUKR1370
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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: 53 YR
• Patient Sex: Female