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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 33305
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/28/2022
Event Type  Injury  
Event Description
It was reported that the male external catheter was not adhering and falling off.Stated that they had trouble fitting the catheter, had bleeding from bladder and had a bladder cancer.It was unknown what medical intervention was provided.
 
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 male external catheter was not adhering and falling off.Stated that they had trouble fitting the catheter, had bleeding from bladder and had a bladder cancer.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿operator error¿.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.The lot number was 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.¿ 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.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14166721
MDR Text Key289737887
Report Number1018233-2022-02760
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070815
UDI-Public(01)00801741070815
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 06/28/2022
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 Number33305
Device Catalogue Number33305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/21/2022
Supplement Dates Manufacturer Received06/28/2022
Supplement Dates FDA Received07/17/2022
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) Other;
Patient SexMale
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