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	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer identified 41 foley trays as mislabeled.This tray with ref# a942216 foley tray should be a non-latex foley.However, lot #ngjx4320 had been labeled incorrectly with a latex tray.All around, this tray was mislabeled.They had pulled all of their products from the shelf, and they were currently pulling them from the floors.They have placed an order of l# 370941 a319516am to start replacing this tray.Customer submitted a 2nd complaint.Per additional information received via email on 14feb2025, it was reported that on 12february2025 they had submitted the same complaint but on 14february2025 this hospital found 4 more foley trays that were mislabeled.This was the same lot number from the 1st complaint.
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
The reported event is confirmed manufacturing related.Visual evaluation noted received 3 photo samples.First photo: label indicates pcn as a942216, lot number as ngjx4320.Second photo: tray packaging shows indicates pcn as a303316a and indicates latex catheter included in kit.Third photo: shipping box label which indicates pcn as a942216, lot number as ngjx4320, and indicates lubri-sil foley catheter tray.As all three photos received do not unanimously indicate the same information the reported event is confirmed.Visual evaluation of the returned sample noted one opened (with original packaging), surestep foley tray system.Visual inspection noted the tray package has a303316a and the label on the back of the package has a942216.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling could not have prevented the reported event.Correction- d, 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 identified 41 foley trays as mislabeled.This tray with ref#a942216 foley tray should be a non-latex foley.However, lot #ngjx4320 had been labeled incorrectly with a latex tray.All around, this tray was mislabeled.They had pulled all of their products from the shelf, and they were currently pulling them from the floors.They have placed an order of lot# 370941, a319516am to start replacing this tray.Customer submitted a 2nd complaint.Per additional information received via email on 14feb2025, it was reported that on 12february2025 they had submitted the same complaint but on 14february2025 this hospital found 4 more foley trays that were mislabeled.This was the same lot number from the 1st complaint.
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 customer identified 41 foley trays as mislabeled.This tray with ref#a942216 foley tray should be a non-latex foley.However, lot #ngjx4320 had been labeled incorrectly with a latex tray.All around, this tray was mislabeled.They had pulled all of their products from the shelf, and they were currently pulling them from the floors.They have placed an order of l# 370941 a319516am to start replacing this tray.Customer submitted a 2nd complaint.Per additional information received via email on 14feb2025, it was reported that on 12february2025 they had submitted the same complaint but on 14february2025 this hospital found 4 more foley trays that were mislabeled.This was the same lot number from the 1st complaint.
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.First photo: label indicates pcn as a942216, lot number as ngjx4320, and expiration date as 31may2027.Second photo: tray packaging shows indicates pcn as a303316a and indicates latex catheter included in kit.Third photo: shipping box label which indicates pcn as a942216, lot number as ngjx4320, and indicates lubri-sil foley catheter tray.As all three photos received do not unanimously indicate the same information the reported event is confirmed.Visual evaluation of the returned sample noted one opened (with original packaging), surestep foley tray system.Visual inspection noted the tray package has a303316a and the label on the back of the package has a942216.A dhr review was not required because the investigation was confirmed by the capa association.A capa # 11598314 / sa #ucc-25-5282-fa has been opened for this failure.A labeling review are not required because the investigation was confirmed by the capa association.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 customer identified 41 foley trays as mislabeled.This tray with ref# (b)(4).Foley tray should be a non-latex foley.However, lot #ngjx4320 had been labeled incorrectly with a latex tray.All around, this tray was mislabeled.They had pulled all of their products from the shelf, and they were currently pulling them from the floors.They have placed an order of l# 370941 a319516am to start replacing this tray.Customer submitted a 2nd complaint.Per additional information received via email on 14feb2025, it was reported that on 12february2025 they had submitted the same complaint but on 14february2025 this hospital found 4 more foley trays that were mislabeled.This was the same lot number from the 1st complaint.

• 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: 21493816
• Report Number: 1018233-2025-01366
• Device Sequence Number: 8547241
• 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: Other,Notification,Recall
• 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: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/12/2025; 08/11/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/14/2025; 07/03/2025; 08/12/2025
• 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