MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®

Catalog Number	A319516AM
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: 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
It was reported that the customer stated they opened up product a319516am, which lists it had a molex connector temp foley, but the wrong foley tray-syringe was inside the kit which had a monoplug connector instead.Normally that monoplug was used inside the a319516a series foley kits.They were not sure how a mono-plug from a319516a made it was way into a molex foley kit a319516am.They asked the customer to double check if their foley kit was a319516am and not a319516a, and they confirmed with a picture that it was a319516am.Long story short they said wrong foley was put inside the foley kit.
Event or Problem Description
It was reported that the customer stated they opened up product a319516am, which lists it had a molex connector temp foley, but the wrong foley tray-syringe was inside the kit which had a monoplug connector instead.Normally that monoplug was used inside the a319516a series foley kits.They were not sure how a mono-plug from a319516a made it was way into a molex foley kit a319516am.They asked the customer to double check if their foley kit was a319516am and not a319516a, and they confirmed with a picture that it was a319516am.Long story short they said wrong foley was put inside the foley kit.
Additional Manufacturer Narrative
The reported event is inconclusive.Visual: received one photo sample that shows two packaging labels.One packaging label states pcn as a319516am and the other packaging label does not clearly indicate the pcn due to picture quality.As both product labels are not clear due to the condition of the photo sample received the reported event is inconclusive.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have impacted the reported event.Correction: d, e, h udi format updated with available product information per gudid.H11: 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21282283
• Report Number: 1018233-2025-00447
• Device Sequence Number: 15835126
• Product Code: MJC
• UDI-Device Identifier: 00801741073892
• UDI-Public: (01)00801741073892(11)240904(17)260131(10)NGJU4342
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: A319516AM
• Device Lot Number: NGJU4342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: Other
• Patient Sex: Unknown