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 material # a303316a lot # ngjx6399 out date 31may2027.There was a picture of the front and the back.One tray said latex free the other said latex, they were the same foley trays with the same product number, lot number and outdate.
Additional Manufacturer Narrative
The reported event was confirmed by capa/sa association to be manufacturing related as per capa#: 11598314 / sa #ucc-25-5282-fa.Visual evaluation of the returned sample noted four unopened (with original packaging), surestep foley tray system.Visual inspection of the sample noted that the four surestep foley trays that upon unpackaging present mislabeling was present in all returned trays.Tray 3 and 4 indicated with a303416a, and the tray 1 and 2 indicated with a303316a.This does not meet specification per ip7602974, revision 10 which states " part number, lot and expiration date must be correct and legible on the trays and box label".This specific complaint allegation was part of a broader investigation captured in per capa # 11598314 / sa #ucc-25-5282-fa.The capa investigation conducted a broader review of labeling, complaints, risk management file, raw materials, and manufacturing changes for this product.Based on the results of the investigation, no additional actions can be taken at this time.Dhr review for manufacturing lot no.Ngjx6399 for catalog number: a303316a (urnmtrfolytryclctn) being the reported lot did not show any rejects, planned deviations, reworks or component quality issues regarding visual and physical evaluation by ip7602974 rev 10.Corrections: d, e, h.Udi format updated with available product information per gudid.H11: sections 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 material#: a303316a, lot#: ngjx6399 out date 31may2027.There was a picture of the front and the back.One tray said latex free the other said latex, they were the same foley trays with the same product number, lot number and outdate.Per customer response received on 18jun2025, still they were having the product in their office.Asked for a serial number.The pictures had the lot numbers.No intervention required.No trouble shooting.

• 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: 22236634
• Report Number: 1018233-2025-04698
• Device Sequence Number: 9098831
• 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: WI
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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?: Device Returned to Manufacturer
• 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: 11/21/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Sex: Unknown