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

Model Number	4A7044
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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 there was hardly any coude at the tip of the catheter.Follow up via phone on 02dec2020, customer noted that the catheters are not curved enough they seem straight.
Additional Manufacturer Narrative
The reported event was unconfirmed as the product meets the specifications.Three urethral catheter kits were returned unopened in original package.No visual damage was noted on any of the catheter.Each catheter had some bend to the coude tip.As the products were returned unopened they were not used for diagnostic or treatment purposes.A potential root cause for this failure mode was unable to determine due to the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not required due to the reported event was unconfirmed.Correction: e 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that there was hardly any coude at the tip of the catheter.Per follow up via phone on (b)(6) 2020 the customer noted that the catheters were not curved enough they seem straight.Per follow up on (b)(6) 2021 the 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.Per follow up on (b)(6) 2021 the customer stated that the issue was not with one particular lot and with many lots over the years and the issue was constant.Also stated that the coude was either not defined enough or not there at all.Per follow up on (b)(6) 2021 it was stated that the coude catheters work they are great but 90 percentage of them did not have nearly enough coude to be effective.

• Brand Name: BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: URETHRAL CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11060206
• Report Number: 1018233-2020-21940
• Device Sequence Number: 1193152
• 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): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2021

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: 11/30/2021
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGDQ2849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 08/28/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 09/20/2021
• 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