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	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one case of foley tray was labeled with the incorrect reference supposed to be pcn #a942216 but had pcn #a303316a.They pulled product out and it did appear to be what they intended to order.Per additional information received on 15feb2025, it was reported that the sheet inside the package had a different item number.When opening the case, the incorrect item a303316a was in the box the items have 2 different manufacturing numbers on them, so not able to use because of this.Luckily, none of the incorrect trays were used quantity 10 per case.
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-25-5282 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: 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 one case of foley tray was labeled with the incorrect reference supposed to be pcn #a942216 but had pcn #a303316a.They pulled product out and it did appear to be what they intended to order.Per additional information received on 15feb2025, it was reported that the sheet inside the package had a different item number.When opening the case, the incorrect item a303316a was in the box the items have 2 different manufacturing numbers on them, so not able to use because of this.Luckily, none of the incorrect trays were used quantity 10 per case.
Additional Manufacturer Narrative
(b)(4) 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 #(b)(4).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 1unopened box (with original packaging), (qty.Of 10) of sure step foley tray system.Visual inspection of the sample noted that the ten surestep foley trays packaged with a303316a, and the shipping box label had a942216.This does not meet specification which states part number, lot and expiration date must be correct and legible on the trays and box label.A dhr review was not required because the investigation was confirmed by the capa association.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 one case of foley tray was labeled with the incorrect reference supposed to be pcn #(b)(6) but had pcn #(b)(6).They pulled product out and it did appear to be what they intended to order.Per additional information received on 15feb2025, it was reported that the sheet inside the package had a different item number.When opening the case, the incorrect item (b)(6) was in the box the items have 2 different manufacturing numbers on them, so not able to use because of this.Luckily, none of the incorrect trays were used quantity 10 per case.

• 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: 21469053
• Report Number: 1018233-2025-01282
• Device Sequence Number: 8840503
• 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: IA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 08/07/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/11/2025
• 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