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 Consequences Or Impact To Patient (2199); 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.The device was not returned.
Event or Problem Description
It was reported that there was no bump at the funnel end of the coude catheter to indicate that it is coude but the catheter did have a curve.
Event or Problem Description
It was reported that there was no bump at the funnel end of the coude catheter to indicate that it is coude but the catheter did have a curve.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.Two touchless plus samples were returned.One was opened and the other unopened.The catheter of the opened sample was removed from its bag and examined.No coude indicator bump was found.The unopened sample was opened and the catheter was removed from its bag.It also did not contain a coude indicator bump.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.Corrections: d4, d10, h3.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 there was no bump at the funnel end of the coude catheter to indicate that it is coude but the catheter did have a curve.
Additional Manufacturer Narrative
Upon further review, additional information was received in which bard/bd medical has determined that this mdr event is not reportable.

• 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: 9293101
• Report Number: 1018233-2019-07137
• Device Sequence Number: 2282927
• Product Code: FCM
• UDI-Device Identifier: 00801741030536
• UDI-Public: (01)00801741030536
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGDV0786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 06/23/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/07/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1