MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL COUDE URETHRAL CATHETER; TOUCHLESS VINYL URETHRAL CATHETER

Model Number	4A7114
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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.
Event or Problem Description
It was reported that the patient was using these bard vinyl coude urethral catheter kits due to urinary tract infections and their complaint was that the catheter did not had a line on it so the patient could keep the tip up.
Event or Problem Description
It was reported that the patient was using these bard vinyl coude urethral catheter kits due to urinary tract infections and their complaint was that the catheter did not had a line on it so the patient could keep the tip up.
Additional Manufacturer Narrative
The reported event was unconfirmed as the product was not designed with a coude tip indicator.No sample was returned for evaluation.No root cause could be found because the reported event was unconfirmed.The lot number was unknown; therefore, the device history record could not be reviewed.As the reported event was unconfirmed a labeling review is not required.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.H3 other text : the device was not returned.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL COUDE URETHRAL CATHETER
• Common Device Name: TOUCHLESS VINYL URETHRAL 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12357386
• Report Number: 1018233-2021-05105
• Device Sequence Number: 3811717
• Product Code: FCM
• UDI-Device Identifier: 00801741046452
• UDI-Public: (01)00801741046452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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 Model Number: 4A7114
• Device Catalogue Number: 4A7114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male