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

Model Number	4A7044
Medical Device Problem Codes	Nonstandard Device (1420); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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 coude was curved and some just a slight curve.Follow up via phone on 26feb2021, when the catheters weren¿t curved enough, the customer had a hard time inserting and using them.
Additional Manufacturer Narrative
The reported event was unconfirmed.No root cause could be found because the reported event was unconfirmed.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the coude was curved and some just had a slight curve.Follow up via phone on 26feb2021, when the catheters weren¿t curved enough, the customer had a hard time inserting and using them.Per follow up on 02jun2021, customer stated that the coude touchless catheter kits have virtually no coude.As a paraplegic, these kits could be invaluable if they were more user friendly.When the catheter had a well defined coude at least 45 degrees, they work almost 100 percent of the time.Per follow up on 08jun2021, customer stated that the issue was not with one particular lot and it had been many lots over the years and the issue was constant.Also added that coude was either not defined enough or not there at all.Per follow up on 16jun2021, it was stated that the coude catheters work great, but 90 percentage of them do not have nearly enough coude to be effective.

• Brand Name: BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: COUDE URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11510120
• Report Number: 1018233-2021-01378
• Device Sequence Number: 17075034
• Product Code: FCM
• UDI-Device Identifier: 00801741030536
• UDI-Public: (01)00801741030536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 08/31/2022
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGEV4147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other