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

Catalog Number	0601680
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a repair kit placement procedure using the hickman/leonard/broviac repair kit.Post the procedure it was noted that the metal pin moved out of slice area.There was no reported patient injury.
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 return of sample is pending.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.
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 photo was provided for review and one 12.5fr hickman t/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The photo shows a partial view of the catheter extension leg in which the actual location and the correct location of the metal pin are marked.In the returned sample, two splice sleeves were observed to the extension leg of the white luer proximal to the trifurcate.A s-shaped split was noted one portion of the white luer extension leg, in between the attached splice sleeves.A split was noted on the white luer extension leg, distal to the bifurcate.The splice sleeve on the white luer extension leg was inspected, and no metal pin was noted within.The split on the white luer extension leg, distal to the bifurcate was examined and what appeared to be the detached metal pin from the splice sleeve was noted.Therefore, the investigation is confirmed for the reported device dislodged, material puncture or hole issues and identified burst issue.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 g3, h6 (device, 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 repair kit placement procedure using the hickman/leonard/broviac repair kit.On (b)(6) 2025, post the procedure it was noted that the metal pin moved out of slice area.The internal metal pin has traveled down the line and created a hole outside the sleeve in the repair zone.Line was replaced.There was no reported patient injury.

• Brand Name: CATHETER ACCESSORIES
• 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: 23484226
• Report Number: 3006260740-2025-08456
• Device Sequence Number: 10499730
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415(17)260331(10)REHR1028
• 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: 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 Expiration Date: 03/31/2026
• Device Catalogue Number: 0601680
• Device Lot Number: REHR1028
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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