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

Catalog Number	5587000
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 return of the sample is pending.However, a photo was 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
A patient underwent a port placement procedure using vascath accessories.During the preparation of the port placement procedure the product allegedly found damaged.It was further reported that incorrect packaging.Reportedly, material not in original case.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical sample was returned for evaluation.One electronic photo was provided and reviewed.The photo shows the partial view of packaging with the attached label.Product label, batch and other labeling information were match and correct as per tw.However, the incorrect package or product cannot be verified with provided photo and without physical sample.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported incorrect packaging and miss assembled issues as provided evidence are not sufficient to confirm the issue.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.D1 (medical device brand name), d4 (unique identifier (udi) #), g3, h6 (patient, 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
A patient underwent a port placement procedure using vascath accessories.During the preparation of the port placement procedure the product allegedly found damaged.It was further reported that incorrect packaging.Reportedly, material not in original case.There was no patient contact.

• Brand Name: CATHETER REPAIR KIT
• 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: 22159009
• Report Number: 3006260740-2025-03675
• Device Sequence Number: 7369292
• Product Code: NFK
• UDI-Device Identifier: 00801741045080
• UDI-Public: (01)00801741045080(11)250322(17)261130(10)REKP1543
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K770977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 5587000
• Device Lot Number: REKP1543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2025
• 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