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); Fracture (1260); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.However, photos were provided for review.The investigation of the reported event is currently underway.H11: 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 male patient underwent for chronic catheter inserted.On (b)(6) 2025 it was reported that four days later, post a chronic catheter placement, the lumen was allegedly found leakage, and the blue lumen was visually inspected and also found to be damaged at this time.It was further reported that the lumen was allegedly found slits near the hub on two of the lumens and the blood found to be bleed back 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.Along with returned sample, two photos were provided for review.Visual, microscopic, tactile and functional evaluations were performed on the returned device.Splits, were noted on the white and blue luer extension legs, proximal to the hubs.No anomalies were noted to the red luer extension leg.The edges on the splits on the white and blue luer extension legs were noted to be jagged.Upon infusion of the white luer, leaks were observed from the split on the extension leg.Upon infusion of the red luer, no leaks were observed.Upon infusion of the blue luer, leaks were observed from the split on the extension leg.Therefore, the investigation is confirmed for the reported fracture and fluid leak issues.However, the investigation is inconclusive for the reported reflux within device issue as the exact circumstance at the time of the reported event was unknown.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, h3, h6 (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 male patient underwent for chronic catheter inserted.On (b)(6) 2025, it was reported that four days later, post a chronic catheter placement, the lumen was allegedly found leakage, and the blue lumen was visually inspected and also found to be damaged at this time.It was further reported that the lumen was allegedly found slits near the hub on two of the lumens and the blood found to be bleed back 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: 22000301
• Report Number: 3006260740-2025-03006
• Device Sequence Number: 20661353
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975(17)290128(10)HUJP0296
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: HUJP0296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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 Age: 29 YR
• Patient Sex: Male