MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REPAIR WHITE ADAPTER LEG; PORT AND CATHETER ACCESSORIES

Catalog Number	0601680
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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 provided by bd represents all of 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.During the procedure, it was reported the white lumen extension set was allegedly found cracked.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 blue luer extension leg to a hickman catheter was returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.The device was to be clean.The blue luer extension leg was patent to both infusion and aspiration.No leaks were noted.Hydrostatic pressure was applied by clamping the distal end of the extension leg and no leaks were noted as well.Therefore, the investigation is unconfirmed for the reported catheter crack issue as no crack and break was found during sample evaluation for blue luer.The definitive root cause could not be determined based upon available information.It is unknown whether patient/procedural factors contributed to the event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required b5, d4 (unique identifier (udi) #), g3, h6 (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 repair white adapter leg.During the procedure, it was reported the white lumen extension set was allegedly found cracked.There was no reported patient injury.

• Brand Name: REPAIR WHITE ADAPTER LEG
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23252427
• Report Number: 3006260740-2025-07590
• Device Sequence Number: 13323507
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415(11)240501(17)261130(10)REJQ2072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830406
• 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): 01/19/2026

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: 0601680
• Device Lot Number: REJQ2072
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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