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

Model Number	4A7044
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 coude indicators were missing from the catheters.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Two touchless plus catheter were returned.One touchless catheter was returned opened, not containing its original packaging, while the other was sealed in its original packaging.During dimensional evaluation, it was found that both catheters were missing their coude indicators.A potential root cause for this failure could be "machine error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed as the reported event cannot be caused by the user.H11:section a through f - the information provided by bd represents all of 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 coude indicators were missing from the catheters.
Event or Problem Description
It was reported that the coude indicators were missing from the catheters.
Additional Manufacturer Narrative
Upon additional information received, bard/bd medical has determined that this mdr event is not reportable.H11:section a through f - the information provided by bd represents all of 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 TOUCHLESS PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: COUDE TOUCHLESS PLUS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9525309
• Report Number: 1018233-2019-08266
• Device Sequence Number: 19554395
• Product Code: FCM
• UDI-Device Identifier: 00801741030536
• UDI-Public: (01)00801741030536
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2020

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: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGDQ0652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/11/2020; 06/23/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/13/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1