MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER

Catalog Number	897216
Medical Device Problem Codes	Disconnection (1171); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foley tray handle broke off.It was noted that the given lot# was ngjz2064.
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 cause unknown.Visual evaluation noted visual inspection of the return sample noted the handle was disconnected from the drainage bag.Therefore, the reported event is confirmed and does not meet specifications per (b)(4) rev 2 which states "no damage, punctures, or tears to the header bag." the labeling was reviewed and found to be adequate.Dhr review did not show any problems or conditions that would have contributed to the reported event.Based on the results of the investigation no additional actions are required at this time.Corrections: d, e, f, h.Udi format updated with available product information per gudid.H11: sections 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 foley tray handle broke off.It was noted that the given lot# was ngjz2064.Per customer via phone on 24jun2025, it was reported that the buttonhole gets stretched out going into the bag.Stated that they believed they were playing a part in it and could not explain what they were doing.They stated that it kept happening, so now believed the bags were poorly made.Stated that they sent a sample back last week, and not willing to send another one at this time.They would like a results letter.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• 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: 22324973
• Report Number: 1018233-2025-04985
• Device Sequence Number: 21088359
• Product Code: EZL
• UDI-Device Identifier: 00801741020322
• UDI-Public: (01)00801741020322(11)250211(17)270630(10)NGJZ2064
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 897216
• Device Lot Number: NGJZ2064
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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