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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 Problem Loss of or Failure to Bond (1068)
Patient Problem Urinary Tract Infection (2120)
Event Date 07/23/2021
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 experienced urinary tract infection as the catheter was sliding off and the opening part was closing.Patient had used product for more than 60 days.It was unknown what medical intervention was provided for the urinary tract infection.
 
Event Description
It was reported that the patient experienced urinary tract infection as the catheter was sliding off and the opening part was closing.Patient had used product for more than 60 days.It was unknown what medical intervention was provided for the urinary tract infection.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "operator error ".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: "intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: 1) verify correct size prior to use.2) trim pubic hair if necessary.3) wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.4) open package at perforation.Remove catheter from plastic insert, if present.5) place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.6) unroll the catheter over penis.7) gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.8) connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: 1) ensure drainage bag is empty.2) disconnect catheter from the drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Disposal: after removal, dispose by placing the used catheter into a waste container.".
 
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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
MDR Report Key12328818
MDR Text Key266836343
Report Number1018233-2021-04970
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070754
UDI-Public(01)00801741070754
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
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
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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