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

Catalog Number	4A5144
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intermittent catheter had no eyelet and iodine leaked out dried up missing.Per customer follow up information received on 17may2024, it was reported that once they opened the kit, it contained a catheter without an eyelet.The area where the eyelet was supposed to be was just smooth.It was also reported that the corner was missing off the swabs which caused the betadine to leak out into the kit.The solution did not spill onto anything, but it was dried up inside of the kit.Customer discarded the kit and used another one.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "inappropriate package design".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "instructions for use: preparing for catheterization: open kit and remove contents.The gloves are not necessary to maintain aseptic conditions during the procedure.The gloves are for the operator's protection.Male/female catheterization: remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.Slide the catheter halfway into the insertion tip.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.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.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.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.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.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." 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.
Event or Problem Description
It was reported that the intermittent catheter had no eyelet and iodine leaked out dried up missing.Per customer follow up information received on 17may2024, it was reported that once they opened the kit, it contained a catheter without an eyelet.The area where the eyelet was supposed to be was just smooth.It was also reported that the corner was missing off the swabs which caused the betadine to leak out into the kit.The solution did not spill onto anything, but it was dried up inside of the kit.Customer discarded the kit and used another one.Per customer follow information received via phone on 25jun2024, it was reported that the kit was sealed but the iodine looked like it had leaked and dried.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19459607
• Report Number: 1018233-2024-03260
• Device Sequence Number: 15446893
• Product Code: FCM
• UDI-Device Identifier: 00801741030550
• UDI-Public: (01)00801741030550
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 06/25/2024

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 Catalogue Number: 4A5144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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