MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERTRIALYSIS, PC EXTENSION LEGS; ACUTE DIALYSIS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by medwatch, guidewire tip fragment found after central line placement failure.Thin linear density measuring approximately 1.8cm, presumed guidewire tip, is seen within the right transverse foreman of c6 extending to the right neural foramina of c6-c7, possibly within the right vertebral artery versus vertebral venous plexus.Two additional punctuate hyper density is notes in the svc, possibly a guidewire fragment.Catheter was removed, and a new one was placed.Patient did not have nay symptoms related to the retained guidewire fragment.
Additional Manufacturer Narrative
H11: 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
Additional information received 01-july-2025: ct neck soft tissue without iv contrast was performed to check for guidewire tip in vessel.Impression: thin linear density measuring approximately 1.8cm, presumed guidewire top is seen within the right transverse foramen of c6 extending to the right neural foramina of c6-c7, possibly within the right vertebral artery versus vertebral venous plexus.Additional puncture hyperdensity is noted in the svc, possibly a guidewire fragment.
Additional Manufacturer Narrative
H11: 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.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Additional Manufacturer Narrative
H11: 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.The complaint of a broken guidewire was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one sealed 13fr trialysis catheter kit.The kit components were macroscopically and microscopically inspected but no remarkable features were identified.Based on the available evidence, the customer's reported defect could not be confirmed.

• Brand Name: POWERTRIALYSIS, PC EXTENSION LEGS
• Common Device Name: ACUTE DIALYSIS CATHETER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22301627
• Report Number: 3006260740-2025-04116
• Device Sequence Number: 8837818
• Product Code: NIE
• UDI-Device Identifier: 00801741041945
• UDI-Public: (01)00801741041945(11)241127(17)280229(10)REJX2026
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2025

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 Model Number: N/A
• Device Catalogue Number: 5613150
• Device Lot Number: REJX2026
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/01/2025; 08/14/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/24/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American