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

Catalog Number	A303316A
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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 they were reaching out on behalf of aspirus wausau hospital.They had the end user reach out with the concern/ question.Product #a303316a, lot #ngjx6399, out date (b)(6) 2027.There was a picture of the front and the back.One tray says latex free the other says latex, they were the same trays with the same product number, lot number and outdate.They need to know how one can be latex and the other latex free.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.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 they were reaching out on behalf of (b)(6) hospital.They had the end user reach out with the concern/ question.Product#: a303316a, lot#: ngjx6399 out date 2027-05-31.There was a picture of the front and the back.One tray says latex free the other says latex, they were the same trays with the same product number, lot number and outdate.They need to know how one can be latex and the other latex free.
Additional Manufacturer Narrative
Ucc-25-5282_5319 field action has been initiated by bd.Customers will be instructed to discard product or return product to bd for replacement or credit.Capa 11598314 has been initiated to investigate root cause of the problem.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: 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.
Event or Problem Description
It was reported that they were reaching out on behalf of (b)(6) hospital.They had the end user reach out with the concern/ question.Product #a303316a, lot #ngjx6399 out date 2027-05-31.There was a picture of the front and the back.One tray says latex free the other says latex, they were the same trays with the same product number, lot number and outdate.They need to know how one can be latex and the other latex free.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.Product labeling was reviewed for this investigation.The labeling is found to be adequate as it states.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 they were reaching out on behalf of (b)(6) hospital.They had the end user reach out with the concern/ question.Product #a303316a lot #ngjx6399 out date 2027-05-31.There was a picture of the front and the back.One tray says latex free the other says latex, they were the same trays with the same product number, lot number and outdate.They need to know how one can be latex and the other latex free.Per additional information received via mail on 30july2025 from bd rep: "it was reported that all they know what was reported.The item and lot number were in the description product #a303316a lot #ngjx6399.".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® 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, GA 30014 ; 7707846100
• MDR Report Key: 22131365
• Report Number: 1018233-2025-04120
• Device Sequence Number: 7357340
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793(11)241204(17)270531(10)NGJX6399
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification,Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2025

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: A303316A
• Device Lot Number: NGJX6399
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 06/12/2025; 10/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/23/2025; 07/03/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UCC-25-5282_5319 FIELD A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown