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	02/19/2025
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 customer had 8 foley trays were labeled a942216 mislabeled.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned two-photo sample noted one opened (with original packaging), latex-free foley tray.Visual inspection of the two-photo sample noted that the product outside packaging was label of a303316a but the product inside information was label of a942216.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: intended for use in the drainage and/or collection and/or measurement of urine, generally.Drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterile.Warning: do not use if allergic to iodine.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Correction: b, d, e, f, 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 customer had 8 foley trays were labeled a942216 mislabeled.Per additional information received via email on 24mar2025, it was reported that the facility (mgmc) was alerted by our other branch (crmc) that 16fr trays were mislabeled.They started looking and alerted the departments who could had been using these trays.Two particular orders were identified to have these mislabeled trays at mercy gilbert.All 8 trays have a label of a303316a on its front but have the right label on its back, a942216.No impact to the patient they were able to notice the discrepancy right away.
Event or Problem Description
It was reported that customer had 8 foley trays were labeled a942216 mislabeled.Per additional information received via email on 24mar2025, it was reported that the facility (mgmc) was alerted by our other branch (crmc) that 16fr trays were mislabeled.They started looking and alerted the departments who could had been using these trays.Two particular orders were identified to have these mislabeled trays at mercy gilbert.All 8 trays have a label of a303316a on its front but have the right label on its back, a942216.No impact to the patient they were able to notice the discrepancy right away.
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.
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 reported event was confirmed by capa/sa association to be manufacturing related as per capa # 11598314 / sa #ucc-25-5282-fa, the root cause identified is: 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 two-photo sample noted one opened (with original packaging), latex-free foley tray.Visual inspection of the two-photo sample noted that the product outside packaging was label of a303316a but the product inside information was label of a942216.A dhr review was not required because the investigation was confirmed by the capa association.A labeling review are not required because the investigation was confirmed by the capa association.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 customer had 8 foley trays were labeled a942216 mislabeled.Per additional information received via email on 24mar2025, it was reported that the facility (mgmc) was alerted by our other branch (crmc) that 16fr trays were mislabeled.They started looking and alerted the departments who could had been using these trays.Two particular orders were identified to have these mislabeled trays at (b)(6).All 8 trays have a label of a303316a on its front but have the right label on its back, a942216.No impact to the patient they were able to notice the discrepancy right away.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 21546475
• Report Number: 1018233-2025-01516
• Device Sequence Number: 20797575
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 06/12/2025; 08/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/29/2025; 07/03/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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