MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER

Model Number 33302

Device Problems Loss of or Failure to Bond (1068); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient experienced retraction while using the male external catheter, which caused a bulb at the end of the catheter that leads to the leaking.Also, the patient got a red bump on the penis, although there was no confirmation whether the patient thought the bump was caused by these externals.Per customer via phone on 22oct2021, the catheters would lose grip and slide down, and would stick to themselves at the head of the penis.The urine would collect at the end of the catheter instead of moving into the hose of the catheter bag.The patient changed back to the natural catheter.Also stated that the customer had urinary tract infection (uti) with prescription medication from a physician related to urine building up at the tip of the penis.Even when asked, the patient would not specify which catheter or bedside urinary drain bag they used.The uti was about two weeks ago, and the latest doctor's appointment indicated the patient was well.The customer suggested an air release valve be added to the tubing so that it could be released, causing air to push the urine towards the bag and preventing urine from gathering at the tip of the penis.It was reported that the rash and redness was a result of a self-made tourniquet from the velcro straps of a leg bag.The patient was using the tourniquet to prevent the head of the penis from retracting into the shaft.The rash was a result of the velcro rubbing on his skin.

Event Description

It was reported that the patient experienced retraction while using the male external catheter, which caused a bulb at the end of the catheter that leads to the leaking.Also, the patient got a red bump on the penis, although there was no confirmation whether the patient thought the bump was caused by these externals.Per customer via phone on (b)(6) 2021, the catheters would lose grip and slide down, and would stick to themselves at the head of the penis.The urine would collect at the end of the catheter instead of moving into the hose of the catheter bag.The patient changed back to the natural catheter.Also stated that the customer had urinary tract infection (uti) with prescription medication from a physician related to urine building up at the tip of the penis.Even when asked, the patient would not specify which catheter or bedside urinary drain bag they used.The uti was about two weeks ago, and the latest doctor's appointment indicated the patient was well.The customer suggested an air release valve be added to the tubing so that it could be released, causing air to push the urine towards the bag and preventing urine from gathering at the tip of the penis.It was reported that the rash and redness was a result of a self-made tourniquet from the velcro straps of a leg bag.The patient was using the tourniquet to prevent the head of the penis from retracting into the shaft.The rash was a result of the velcro rubbing on his skin.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation.A potential root cause for the failure could be "user deviation from ifu".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "description/indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.5) connect to drainage device.Directions: to remove: gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." 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.

• Brand Name: ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL 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: 12796522
• MDR Text Key: 282975639
• Report Number: 1018233-2021-07213
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33302
• Device Catalogue Number: 33302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male