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	Burst Container or Vessel (1074); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
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 was undergoing a catheter placement procedure, for an unknown medical condition.During the procedure, it was reported that the lumen was allegedly found ballooned where reinforced.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: one 12.5fr hickman t/l catheter with a repair catheter were returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.A partial compound break was noted on the distal portion of the white luer extension leg, proximal to the bifurcate.The edges of the partial diagonal break on the white luer extension leg were noted to be jagged, and the surface was noted to be smooth and looks burst.No evidence indicating loose fitting was noted near the tissue cuff.Therefore, the investigation is confirmed for the identified burst issue.However, the investigation is inconclusive for the reported catheter ballooning issue as provided evidence not sufficient and no catheter ballooning was noted during sample evaluation, however identified burst issue could be result of catheter ballooning.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.D4 (unique identifier (udi) #), 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 was undergoing a catheter placement procedure, for an unknown medical condition.During the procedure, it was reported that the lumen was allegedly found ballooned where reinforced.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: 23177674
• Report Number: 3006260740-2025-07315
• Device Sequence Number: 8991966
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975(11)250403(17)300228(10)HUKQ0526
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: HUKQ0526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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 Sex: Unknown