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

Catalog Number	A942216
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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 customer had a serious issue with this tray#: a942216.This tray with ref#: a942216 should be a non-latex foley.However, lot: ngjx4320 has been labeled incorrectly with a latex foley tray.Please see the images below for a better reference.That was what the outside of the case looks like and it should had trays with ref#: a942216.However, once you open the case, they have trays with ref#: a303316a which were latex, t flip the tray over to the other and they have a sticker with reference#: a942216.
Event or Problem Description
It was reported customer had a serious issue with this tray #a942216.This tray with ref# a942216 should be a non latex foley.However, lot ngjx4320 has been labeled incorrectly with a latex foley tray.Please see the images below for a better reference.That was what the outside of the case looks like and it should had trays with ref # a942216.However, once you open the case, they have trays with ref# a303316a which were latex, t flip the tray over to the other and they have a sticker with reference #a942216.Per additional information received via email on 02apr2025, it was reported that they had multiple trays and cases that were affected by this.
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.A labeling review was not performed because labeling could not have prevented the reported failure.Correction: d, e, g.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.
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.Correction: f, h.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 customer had a serious issuewith this tray #a942216.This tray with ref# a942216 should be a non latex foley.However, lot ngjx4320 has been labeled incorrectly with a latex foley tray.Please see the images below for a better reference.That was what the outside of the case looks like and it should had trays with ref # a942216.However, once you open the case, they have trays with ref# a303316a which were latex, t flip the tray over to the other and they have a sticker with reference #a942216.Per additional information received via email on 02apr2025, it was reported that they had multiple trays and cases that were affected by this.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• 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: 21572051
• Report Number: 1018233-2025-01579
• Device Sequence Number: 18377729
• Product Code: EZL
• UDI-Device Identifier: 00801741074110
• UDI-Public: (01)00801741074110(11)241127(17)270531(10)NGJX4320
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: A942216
• Device Lot Number: NGJX4320
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 06/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/28/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• 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