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

Catalog Number	277716
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the intermittent catheter was all dry rotten.No patient injury reported and sample available.
Event or Problem Description
It was reported that the intermittent catheter was all dry rotten.No patient injury reported and sample available.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted 16 unopened (with original packaging), all purpose urethral catheters.Visual inspection of the 16 samples noted a light, chalky surface film on the catheter.This appearance is consistent with latex bloom, a naturally occurring surface phenomenon seen on latex based products when exposed to heat, humidity, or aging.Latex bloom does not originate from contamination but rather results from migration of internal latex components to the surface over time.All 16 catheters were filled with water as part of functional testing.No issues were observed in any of the samples.All units maintained structural integrity, showed no signs of leakage, and performed as expected.The reported event is unconfirmed.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded.Corrections made to tab 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.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: UTILITY 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: 23180209
• Report Number: 1018233-2025-08711
• Device Sequence Number: 9843667
• Product Code: KOD
• UDI-Device Identifier: 00801741034114
• UDI-Public: (01)00801741034114(11)220721(17)260430(10)NGGT2324
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 277716
• Device Lot Number: NGGT2324
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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