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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER Back to Search Results
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.
 
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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 Key12796522
MDR Text Key282975639
Report Number1018233-2021-07213
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070754
UDI-Public(01)00801741070754
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number33302
Device Catalogue Number33302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/11/2021
Supplement Dates Manufacturer Received01/14/2022
Supplement Dates FDA Received02/03/2022
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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