MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETER; INTERMITTENT CATHETER

Catalog Number	120614
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/14/2025
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 customer received 2 orders of their monthly supply.Both were marked with the correct size, but 1 box was bigger and customer stated it was not a 14f.It¿s to big causing bleeding every time with insertion and they could not use them.It was noted that the given lot# was ngjw3614.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e, g.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 customer received 2 orders of their monthly supply.Both were marked with the correct size, but 1 box was bigger and customer stated it was not a 14f.It¿s to big causing bleeding every time with insertion and they could not use them.It was noted that the given lot # was ngjw3614.Per customer follow up via phone on 05apr2025, it was reported that customer wanted the defective catheters to be replaced.
Event or Problem Description
It was reported that customer received 2 orders of their monthly supply.Both were marked with the correct size, but 1 box was bigger and customer stated it was not a 14f.It¿s to big causing bleeding every time with insertion and they could not use them.It was noted that the given lot# was ngjw3614.Per customer follow up via phone on 05apr2025, it was reported that customer wanted the defective catheters to be replaced.
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 catheter gauging that can lead the catheter oversize (over size).Pfmea ra87p088 rev 3 (miscellaneous catheters manufacturing) was reviewed for this investigation.The reported event is addressed in step/item inspection.A potential root cause for this failure mode could be catheter gauging that can lead the catheter oversize (over size).Based on information in the pfmea, the risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.A review of the device labelling has been conducted for investigation purposed.The ifu is attached on the investigation overview element.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: 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® URETHRAL CATHETER
• Common Device Name: INTERMITTENT 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: 21751870
• Report Number: 1018233-2025-02239
• Device Sequence Number: 12820985
• Product Code: KOD
• UDI-Device Identifier: 00801741029967
• UDI-Public: (01)00801741029967(11)241030(17)260831(10)NGJW3614
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/16/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 120614
• Device Lot Number: NGJW3614
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 07/16/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/03/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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