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	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley tray boxes received were labeled a942216 no latex, however, items in the boxes are labeled a303316a latex.Band packaging on back of product states a942216 with correct lot.
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 was confirmed cause unknown.Visual evaluation of the returned three-photo sample noted one opened (with original packaging), urine meter foley tray system.Visual inspection of the sample noted that the first photo shows the shipping box for surestep foley tray system.The second photo shows the tray for a303316a latex.The third photo shows the inside product information for a942216.This does not meet specification which states " missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted, the clamp must be closed".No actions can be taken at this time since a root cause was not identified.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: surestep foley tray system 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.This preconnected closed system foley tray contains: ¿ lubri-sil® all-silicone foley catheter ¿ statlock® foley stabilization device ¿ control-fittm outlet device ¿ 350 ml urine meter ¿ drainage tube ¿ collection bag (2500 ml) ¿ 3 foam swabs ¿ povidone-lodine packet+ ¿ peri-care kit soap towelettes ¿ hand sanitizer 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 the foley tray boxes received were labeled a942216 no latex, however, items in the boxes are labeled a303316a latex.Band packaging on back of product states a942216 with correct lot.
Event or Problem Description
It was reported that the foley tray boxes received were labeled a942216 no latex, however, items in the boxes are labeled a303316a latex.Band packaging on back of product states a942216 with correct lot.
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 the foley tray boxes received were labeled a942216 no latex, however, items in the boxes are labeled a303316a latex.Band packaging on back of product states a942216 with correct lot.
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 three-photo sample noted one opened (with original packaging), urine meter foley tray system.Visual inspection of the sample noted that the first photo shows the shipping box for surestep foley tray system.The second photo shows the tray for a303316a latex.The third photo shows the inside product information for a942216.This does not meet specification which states " missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted, the clamp must be closed".A dhr review was not required because the investigation was confirmed by the capa association.Labeling review is not required because the investigation was confirmed by the capa association.Correction: g, 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.

• 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: 21535397
• Report Number: 1018233-2025-01476
• Device Sequence Number: 15364358
• 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: NY
• 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,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall,Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2025

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: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 06/12/2025; 08/26/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/24/2025; 07/03/2025; 09/02/2025
• 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