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

Model Number	4A5146
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
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 the betadine swabs were upside down.The packaging had arrows at the top where it indicated peel to open.Stated that the packages stand on the opposite end during storage and for opening.Customer stated that the foil package with betadine swabs were incorrectly placed which caused the betadine to leave the swab and run down the stick.When the customer tried to use the swab, the betadine was mostly dry.They have to add betadine since it was necessary.This had happened very regularly in the last 4 cases they have received.Per additional information received via sample form on 07dec2021, stated that the bard touchless catheter kit contains packages of povidone-iodine swab sticks.Sometimes all the shipments have these packages top-down from the indicated opening arrows (lot# ngfu0124).Stated that when opened, the iodine runs down the stick, not on to the swabs to coat them for use.Customer stated that the next shipment containing lots# ngfu5295, ngfv2674 were that way.Also customer separately stated the packages of swabs from the lot# ngfv2674 did not contained iodine, often the swabs did not contain enough to clean.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), touchless plus unisex catheter kit.Visual inspection of the sample noted 1 touchless plus unisex catheter kit the kit was assembly correctly.Open the iodine pack and noted that the swabs were correctly placed and coated.This meet specification "components arrange and sequence shall be per layout drawing l50014".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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the betadine swabs were upside down.The packaging had arrows at the top where it indicated peel to open.Stated that the packages stand on the opposite end during storage and for opening.Customer stated that the foil package with betadine swabs were incorrectly placed which caused the betadine to leave the swab and run down the stick.When the customer tried to use the swab, the betadine was mostly dry.They have to add betadine since it was necessary.This had happened very regularly in the last 4 cases they have received.Per additional information received via sample form on 07dec2021, stated that the bard touchless catheter kit contains packages of povidone-iodine swab sticks.Sometimes all the shipments have these packages top-down from the indicated opening arrows (lot# ngfu0124).Stated that when opened, the iodine runs down the stick, not on to the swabs to coat them for use.Customer stated that the next shipment containing lots# ngfu5295, ngfv2674 were that way.Also customer separately stated the packages of swabs from the lot# ngfv2674 did not contained iodine, often the swabs did not contain enough to clean.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• Common Device Name: PRE-LUBRICATED VINYL URETHRAL 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13048837
• Report Number: 1018233-2021-08229
• Device Sequence Number: 1608782
• Product Code: FCM
• UDI-Device Identifier: 00801741046438
• UDI-Public: (01)00801741046438
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/02/2022

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: 10/31/2023
• Device Model Number: 4A5146
• Device Catalogue Number: 4A5146
• Device Lot Number: NGFU5295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: White