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

Model Number	4A5142
Medical Device Problem Codes	Partial Blockage (1065); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 touchless plus catheters in this sample order were clogging.
Event or Problem Description
It was reported that the touchless plus catheters in this sample order were clogging.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is considered within specification as the reported failure could not be reproduced.The product was not used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted 50 unopened, unused touchless catheter kits.8 samples were tested according to general inspection level ii.Visual inspection of the sample noted no obvious visible defects.The catheters were removed from all the bags and were flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and drained normally.No root cause could be found because the reported event was unconfirmed.The device history record review was not required as the reported event was unconfirmed.As the reported event is 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.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: VINYL URETHRAL CATHETER KIT
• 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: 11557227
• Report Number: 1018233-2021-01549
• Device Sequence Number: 4087385
• Product Code: FCM
• UDI-Device Identifier: 00801741030543
• UDI-Public: (01)00801741030543
• 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): 11/03/2021

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: 01/31/2023
• Device Model Number: 4A5142
• Device Catalogue Number: 4A5142
• Device Lot Number: NGEU2403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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: Female