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

Model Number 4A7114

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problems Discomfort (2330); Tissue Breakdown (2681); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient used the touchless catheter but could not remove it from urethra.Patient went to the emergency room and waiting for four and half hours but was not seen so left and went home because patient was too uncomfortable due to accident injuries and was unable to void the next day and went to see the urologist.Also stated the urologist was unable to remove the catheter and patient had to have the catheter surgically removed.Patient's urethra was torn and the surgeon determined the catheter was bent, and that¿s why the patient was unable to remove it without surgery.Patient was placed on a foley for several weeks.The surgeon could not determine how the catheter got bent.

Event Description

It was reported that the patient used the touchless catheter but could not remove it from urethra.Patient went to the emergency room and waiting for four and half hours but was not seen so left and went home because patient was too uncomfortable due to accident injuries and was unable to void the next day and went to see the urologist.Also stated the urologist was unable to remove the catheter and patient had to have the catheter surgically removed.Patient's urethra was torn and the surgeon determined the catheter was bent, and that¿s why the patient was unable to remove it without surgery.Patient was placed on a foley for several weeks.The surgeon could not determine how the catheter got bent.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect assembly operation".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." 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 device was not returned.

• Brand Name: BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED VINYL COUDE URETHRAL CATHETER
• Type of Device: TOUCHLESS URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11333937
• MDR Text Key: 232052176
• Report Number: 1018233-2021-00555
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 00801741046452
• UDI-Public: (01)00801741046452
• Combination Product (y/n): N
• PMA/PMN Number: K910653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 4A7114
• Device Catalogue Number: 4A7114
• Device Lot Number: NGET1636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention