MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F; CHRONIC CATHETERS

Catalog Number	0600650
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Material Puncture/Hole (1504); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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 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 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 chronic catheter placement procedure using the hickman cv catheter.During the procedure, the blue lumen was allegedly found leaked.It was further reported that the line was allegedly found small hole.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: one 12.5fr hickman t/l catheter was returned for evaluation.The distal catheter segment was not returned.Gross visual, microscopic, tactile and functional evaluations were performed.A partial diagonal break was noted on the distal portion of the blue luer extension leg, proximal to the bifurcate.Under microscopic observation, the edges of the partial diagonal break on the blue luer extension leg were noted to be uneven.The surface was noted to be smooth throughout.An in-house syringe was attached to the blue luer.Upon infusion, a leak from the partial diagonal break on the extension leg was observed while no water exited the distal end of the catheter.Aspiration was attempted and was unsuccessful as only air returned within the attached syringe.Therefore, the investigation is confirmed for the reported fracture, fluid leak, suction and difficult to flush issues and the investigation is unconfirmed for the reported material puncture/hole issue.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.B5, g3, h6 (device, component, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the hickman cv catheter.During the procedure, the blue lumen was allegedly found leaked.It was further reported that the line was allegedly found small hole.Reportedly, the problem occurred while flushing the catheter with a 10ml normal saline syringe and 4mm tear on the blue lumen.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F
• 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: 22802551
• Report Number: 3006260740-2025-05885
• Device Sequence Number: 12712447
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975(17)290428(10)HUJS1944
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2025

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: 0600650
• Device Lot Number: HUJS1944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/14/2025
• 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
• Patient Sex: Unknown