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

Model Number	4A6144
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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 intermittent catheter had the holes in the tip of the catheters and not been fully punched out which leaves a flap that drags along the inside of the urethra.Customer experienced irritation in the urethra and problems with urination.No medical intervention was reported.Per follow up on 10may2021, patient had amount of bleeding, incontinence and burning.Patient not used one of the defective catheters in almost a week now.No medical intervention was reported.Per follow up on 02jun2021, the new shipment had a number of catheters that were crimped and almost closed.While inserting the catheter sometimes it gets doubled over.
Event or Problem Description
It was reported that intermittent catheter had the holes in the tip of the catheters and not been fully punched out which leaves a flap that drags along the inside of the urethra.Customer experienced irritation in the urethra and problems with urination.No medical intervention was reported.Per follow up on 10may2021, patient had amount of bleeding, incontinence and burning.Patient not used one of the defective catheters in almost a week now.No medical intervention was reported.Per follow up on 02jun2021, the new shipment had a number of catheters that were crimped and almost closed.While inserting the catheter sometimes it gets doubled over.
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 used for patient treatment.Visual evaluation of the returned sample noted one opened (without original packaging), used touchless intermittent catheter.Visual inspection of the sample noted no obvious visible kinks based off the observation of the return sample.The device met relevant specifications stating that "no kinks, blisters, cracks, wrinkles, or voids are permitted.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.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 neither a risk review nor labeling review is 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• Common Device Name: INTERMITTENT CATHETER
• 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: 12089689
• Report Number: 1018233-2021-03920
• Device Sequence Number: 4752009
• Product Code: FCM
• UDI-Device Identifier: 00801741030604
• UDI-Public: (01)00801741030604
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/28/2022

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: 12/31/2025
• Device Model Number: 4A6144
• Device Catalogue Number: 4A6144
• Device Lot Number: NGEZ2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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: Unknown