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 Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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 report received indicating an issue with intermittent catheters, product code 802514.A box of 100 catheters was received, and while most function as expected, occasional units appear to have a larger outer diameter than specified.The discrepancy suggests some catheters may be 15 french (fr) instead of the intended 14 fr, leading to discomfort during use.
Event or Problem Description
It was reported that the report received indicating an issue with intermittent catheters, product code 802514.A box of 100 catheters was received, and while most function as expected, occasional units appear to have a larger outer diameter than specified.The discrepancy suggests some catheters may be 15 french (fr) instead of the intended 14 fr, leading to discomfort during use.
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.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.A labeling review was not performed because labeling could not have prevented the reported failure.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 was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be drainage eye rough causing surface roughness and patient discomfort.The labeling and instructions for use were found to be 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.Correction: d.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 the report received indicating an issue with intermittent catheters, product code 802514.A box of 100 catheters was received, and while most function as expected, occasional units appear to have a larger outer diameter than specified.The discrepancy suggests some catheters may be 15 french (fr) instead of the intended 14 fr, leading to discomfort during use.Per additional information received via email on 11sep2025, it was reported that customer does not have the 'thicker' ones just now, but would like to get a biohazard box, and surely save a few of the ones that customer feel was not the correct size when get to use it.Customer had this issue before and says it just seems like these catheters are 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 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.Correction: d, f, h.
Event or Problem Description
It was reported that the report received indicating an issue with intermittent catheters, product code 802514.A box of 100 catheters was received, and while most function as expected, occasional units appear to have a larger outer diameter than specified.The discrepancy suggests some catheters may be 15 french (fr) instead of the intended 14 fr, leading to discomfort during use.Per additional information received via email on 11sep2025, it was reported that customer does not have the 'thicker' ones just now, but would like to get a biohazard box, and surely save a few of the ones that customer feel was not the correct size when get to use it.Customer had this issue before and says it just seems like these catheters are 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.

• 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: 22414058
• Report Number: 1018233-2025-05575
• Device Sequence Number: 9692472
• Product Code: KOD
• UDI-Device Identifier: 00801741039041
• UDI-Public: (01)00801741039041(11)250111(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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 802514
• Device Lot Number: NGKQ3949
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 10/02/2025; 10/31/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/15/2025; 11/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG