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

Catalog Number	056108
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
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.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 lot#nghy0765 was supposed to be 8fr intermittent catheter but when compared to other 8fr with different lot #¿s these were bigger than an 8fr.
Event or Problem Description
It was reported that lot#nghy0765 was supposed to be 8fr intermittent catheter but when compared to other 8fr with different lot#¿s these were bigger than an 8fr.Per follow up via email response on 21may2024, it was reported that the defect was noticed before use and no patient harm was reported.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual: received 17 unopened urethral catheters in original closed packaging.All samples were measured using french gauge and 15 units were found to be 8fr and 2 units were found to be 9fr.Therefore, the product is within specifications which states all product french size specification: plus or minus one french size.Therefore, the reported event is unconfirmed as the product meets specifications.No root cause could be found because the reported event was unconfirmed.A dhr review is not required as the reported event is unconfirmed.A labelling review is not required as the reported event is unconfirmed.Correction: b,d,g,f,h udi format updated with available product information per gudid as requested.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: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19200518
• Report Number: 1018233-2024-02343
• Device Sequence Number: 15480360
• Product Code: KOD
• UDI-Device Identifier: 00801741033490
• UDI-Public: (01)00801741033490(11)231129(17)280331(10)NGHY0765
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 056108
• Device Lot Number: NGHY0765
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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