MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN,12F; CHRONIC CATHETERS

Catalog Number	0600620
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent hickman d/l catheters placement procedure.On (b)(6), it was reported that the post placement procedure, subcutaneous leakage was confirmed.Additionally, redness was noted around the neck.It was replaced and the actual product was checked with a flash, but no holes or other defects were found.The current status of the patient was unknown.
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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 12fr d/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The red luer and was patent to infusion and aspiration.Upon infusion, thrombus was observed exiting with water on the distal end.No leaks were observed throughout the catheter.The white luer and was patent to infusion and aspiration.No leaks were observed throughout the catheter.An infusion attempt was performed on each luer with dye water and no leaks were observed throughout the catheter.Therefore, the investigation is inconclusive for the reported fluid leak issue as the sample evaluation results indicating no leak and difficulty/issue under laboratory conditions may not be representative of the condition of the device during use.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G1, g3, h6 (method, result, conclusion).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
On (b)(6) 2025, a patient underwent hickman d/l catheters placement procedure.On (b)(6) 2025 it was reported that the post placement procedure, subcutaneous leakage was confirmed.Additionally, redness was noted around the neck.It was replaced and the actual product was checked with a flash, but no holes or other defects were found.The current status of the patient was unknown.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• 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: 22881871
• Report Number: 3006260740-2025-06143
• Device Sequence Number: 15726265
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913(11)231221(17)281028(10)HUHY1103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0600620
• Device Lot Number: HUHY1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown