MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

Catalog Number	A902916
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when foley tray was used for a demonstration of the process with a group of potential customers and suppliers, the lube syringe in the kit did not have the cap, the syringe was almost empty, and the lube was spilled on the tray and other components.It was confirmed that the syringe cap was not located in the tray or the packaging bag, therefore it was concluded that syringe did not have the cap when placed in the tray.Product was not used in any patient it was just for demonstration.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 one-photo sample noted one opened (without original packaging), lubricant syringe.Visual inspection of the one-photo sample noted that the cap was missing off the lubricant syringe.This does not meet specification "the cap must be present and securely attached to the syringe".A root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "improper adhesion of cap to body¿.However, there was insufficient information to confirm this potential root cause.The reported event is addressed and the residual risk for this event is low.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: "caution: this product contains natural rubber latex which may cause allergic reactions.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 latex and may cause balloon to burst." 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 when foley tray was used for a demonstration of the process with a group of potential customers and suppliers, the lube syringe in the kit did not have the cap, the syringe was almost empty, and the lube was spilled on the tray and other components.It was confirmed that the syringe cap was not located in the tray or the packaging bag, therefore it was concluded that syringe did not have the cap when placed in the tray.Product was not used in any patient it was just for demonstration.Per sample received on 21jun2024, it was reported that the returned sample was different from the mentioned sample, a drain bag with pcn 154002 and lot# ngjp4034 was received.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19330378
• Report Number: 1018233-2024-02772
• Device Sequence Number: 14205679
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073(11)240125(17)260131(10)NGHZ0997
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: A902916
• Device Lot Number: NGHZ0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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