MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®

Catalog Number	A319514AM
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that kit contained two lubricant syringes instead of a sterile water syringe and a lubricant syringe.Nurse opened another tray to see if there was another affected one however kit was good to use.
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 unconfirmed.Visual evaluation of the returned two-photo sample noted one opened (with original packaging), lubrisil foley tray.Visual inspection of the first photo sample noted the overview of the tray with two syringes, (1) lubricant syringes and (1) sterile water syringe.The second photo shows the inside product packaging information.The reported failure could not be replicated.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.Correction: d, 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 kit contained two lubricant syringes instead of a sterile water syringe and a lubricant syringe.Nurse opened another tray to see if there was another affected one however kit was good to use.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® 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 30014 ; 7707846100
• MDR Report Key: 22212222
• Report Number: 1018233-2025-04621
• Device Sequence Number: 12799157
• Product Code: MJC
• UDI-Device Identifier: 00801741073885
• UDI-Public: (01)00801741073885(11)241218(17)270430(10)NGJY1148
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: A319514AM
• Device Lot Number: NGJY1148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown