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	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that today a labelling issue was brought to their attention on 16fr foley cath trays.They order item#: a303316a a 16 fr bardex foley cath tray and that was what the outside of the box stated but inside the label/cover sheet of the sealed package states#: a303416a, indicating a lubri-sil cath.To make it more confused, the banded, sterilized wrapped tray itself states item#: a303316a.They attached a scan of the front and back of the package.They checked the other cases in lot#: ngjx6399 on their shelf and they were correct.
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.
Additional Manufacturer Narrative
Ucc-25-5319 field action has been initiated by bd.Customers will be instructed to discard product or return product to bd for replacement or credit.Capa 11946993 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 today a labelling issue was brought to their attention on 16fr foley cath trays.They order item # a303316a a 16 fr bardex foley cath tray and that was what the outside of the box stated but inside the label/cover sheet of the sealed package states # a303416a, indicating a lubri-sil cath.To make it more confused, the banded, sterilized wrapped tray itself states item # a303316a.They attached a scan of the front and back of the package.They checked the other cases in lot # ngjx6399 on their shelf and they were correct.
Additional Manufacturer Narrative
The reported event was confirmed by capa association to be manufacturing related as per capa # 11598314, the root cause identified.Root cause of mixed ifu, occurred during the preparation of the ifu kits by the label room.Technician had inventory of the two different ifus at the same time and he took material from the incorrect box.Visual evaluation of the returned sample noted two unopened (with original packaging), surestep foley trays.Visual inspection of the sample noted that the two surestep foley trays packaged with a303416a, and the product label had 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".A risk review and labeling review are not required because the investigation was confirmed by the capa association.A dhr review was not required because the investigation was confirmed by the capa association.A capa #11598314 has been opened for this failure.Refer to the capa for further action.No additional actions are needed.Correction: 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.
Event or Problem Description
It was reported that today a labelling issue was brought to their attention on 16fr foley cath trays.They order item # a303316a a 16 fr bardex foley cath tray and that was what the outside of the box stated but inside the label/cover sheet of the sealed package states # a303416a, indicating a lubri-sil cath.To make it more confused, the banded, sterilized wrapped tray itself states item # a303316a.They attached a scan of the front and back of the package.They checked the other cases in lot # ngjx6399 on their shelf and they were correct.

• 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: 21849364
• Report Number: 1018233-2025-02721
• Device Sequence Number: 21007410
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793(17)270531(10)NGJX6399
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Remedial Action: Other,Recall,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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
• Date Returned to Manufacturer: 03/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 10/15/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 07/02/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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-25-5319 FIELD ACTION
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown