MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER

Catalog Number	33618
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bard silastic 18 and 20 french foley catheters - recurrence incidents of drainage issues associated with these catheters in post-radical prostatectomies patients.Catheter stopped draining as intended.It was reported that the given lot# was ngjx5831.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter name: (b)(6) hospital.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 bard silastic 18 and 20 french foley catheters - recurrence incidents of drainage issues associated with these catheters in post-radical prostatectomies patients.Cather stopped draining as intended.It was reported that the given lot # was ngjx5831.Per additional information received via email on 06oct2025, no patient harm was reported.All patients that were impacted by this device had foley replaced.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure mode could be eye punch (eye slug not removed) caused no flow/reduce flow at time placement.A review of the device labeling has been conducted for investigation purposes and was found adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Corrections: d, h.Initial reporter name: (b)(6) hospital.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: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• 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: 23065197
• Report Number: 1018233-2025-08175
• Device Sequence Number: 18638848
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070(11)250114(17)290531(10)NGJX5831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K951103
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 33618
• Device Lot Number: NGJX5831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White