MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

Catalog Number	802514
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/30/2025
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 some of the red rubber catheters were thicker than normal and caused discomfort during insertion due to increased thickness.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.A labeling review was not performed because labeling could not have prevented the reported failure.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: d, e.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 some of the red rubber catheters were thicker than normal and caused discomfort during insertion due to increased thickness.No medical intervention was reported.Per customer information received via mail on 01aug2025, it was stated that the only impact from using the thicker catheters was that they were more difficult to pass through urethra.No medical intervention was necessary, but it just makes for an uncomfortable process.Customer had this issue before and stated that it just seems like these catheters were not being checked carefully enough during the manufacturing process.A good "qc" check (quality control) would seem prudent given the personal and medically necessary use of this product.
Event or Problem Description
It was reported that some of the red rubber catheters were thicker than normal and caused discomfort during insertion due to increased thickness.No medical intervention was reported.Per customer information received via mail on (b)(6) 2025, it was stated that the only impact from using the thicker catheters was that they were more difficult to pass through urethra.No medical intervention was necessary, but it just makes for an uncomfortable process.Customer had this issue before and stated that it just seems like these catheters were not being checked carefully enough during the manufacturing process.A good "qc" check (quality control) would seem prudent given the personal and medically necessary use of this product.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted four unopened (with original packaging), urethral foley catheters.Visual inspection of the sample noted using the french gauge all four catheters were measured to be 14fr.This met specification per (b)(4).The reported failure could not be replicated.No root cause could be found because the reported event was unconfirmed.Per (b)(4), as the reported event is unconfirmed, a risk review is not required.Per (b)(4), as the reported event is unconfirmed, a labeling review is not required.Dhr is not required since the reported failure was unconfirmed.Based on the results of the investigation, no additional actions can be taken at this time.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.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL 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: 22412799
• Report Number: 1018233-2025-05559
• Device Sequence Number: 9977839
• Product Code: KOD
• UDI-Device Identifier: 00801741039041
• UDI-Public: (01)00801741039041(11)250507(17)281231(10)NGKQ3949
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

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: Lay User/Patient
• Device Catalogue Number: 802514
• Device Lot Number: NGKQ3949
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 10/27/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/08/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG