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	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
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.It was 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 must add betadine since it was necessary.This had happened very regularly in the last 4 cases they have received.Prior to these 4 cases this problem was rare but did happen.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 no.Ngfu0124).It was 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 (lot no.Ngfu5295), (lot no.Ngfv2674) about half of the packages were that way.Also, customer separately stated that the packages of swabs from the lot no.Ngfv2674 did not contain iodine, often the swabs did not contain enough to clean with.
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.It was 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 must add betadine since it was necessary.This had happened very regularly in the last 4 cases they have received.Prior to these 4 cases this problem was rare but did happen.Per additional information received via sample form on (b)(6) 2021, 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 no.Ngfu0124).It was 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 (lot no.Ngfu5295), (lot no.Ngfv2674) about half of the packages were that way.Also, customer separately stated that the packages of swabs from the lot no.Ngfv2674 did not contain iodine, often the swabs did not contain enough to clean with.
Additional Manufacturer Narrative
The reported event was inconclusive.It is unknown whether the device had met relevant specifications.The product was not used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned photo sample noted one opened (with original packaging), 3 povidone-iodine swabsticks.Visual inspection of the photo sample noted iodine on the 3 swabsticks.The reported event is inconclusive; base off the photo sample showing the 3 swabsticks coated with povidone-iodine.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.The instructions for use were found adequate and state the following: "instructions for use: preparing for catheterization: 1.Open kit and remove contents.2.The gloves are not necessary to maintain aseptic conditions during the procedure.The gloves are for the operator's protection.Male/female catheterization: 1.Remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.2.Slide the catheter halfway into the insertion tip.3.Male - prepare the male urethral meatus and the surrounding area with povidone-iodine swabs provided.Female - prepare the female urethral meatus by holding the outer labia apart and prep the urethral meatus and surrounding area with povidone iodine swabs provided.4.Male - holding the penis, advance the insertion tip into the urethra no further than the flange base.Female - spread the inner labia, advance the insertion tip into the urethra no further than the flange base.Release the inner labia.5.Place your nondominant hand on the finger control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter through bag approximately 1" below the finger control guide and push catheter into urethra.The catheter should be introduced by short, repetitive pushing motions.Repeat motions until catheter reaches bladder and urine starts to flow.6.Allow urine to flow freely, making certain the catheter guide is elevated at least 4" above lower portion of the bag.Allow flow until bladder is empty or until bag is filled.Precaution: it is recommended that the collection bag be held.The catheter could possibly separate from the collection bag when urine increases weight of the bag.7.Withdraw the catheter from the urethra.Remove the remaining portion of the catheter from the collection bag by pulling it through the insertion tip.Note: the catheter is designed to pass through the insertion tip.8.The filled collection bag may be closed by replacing the cap over the insertion tip.Make sure the cap snaps on securely.Specimen collection: to collect a specimen, obtain a sample cup/tube and alcohol wipe.Remove guide tip by pulling tab(s) upward from bag.Wipe port with alcohol.Pour specimen through port at top of bag into cup/tube.Draining bag: remove insertion tip by pulling tab(s) upward from bag.Drain urine through port at top of bag." correction: g 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.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• Common Device Name: 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: 13048993
• Report Number: 1018233-2021-08239
• Device Sequence Number: 17121611
• 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): 06/29/2022

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: NGFV2674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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 Sex: Male
• Patient Race: White