• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER Back to Search Results
Model Number 33103
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
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 customer was trying out male external catheters and have tried two types but both were inconsistently staying in place through the night.Customer mentioned that they have stayed on 2 out of 5 nights (lot: jufv2649 & lot: jufx2803).Inquirer reviewed the direction for use with the customer and found that they were appropriately applying the catheter.Customer reported that they cleaned the penis with soap and water, thoroughly dried it and applied the catheter so that it had a limited number of wrinkles and tried to squeeze it so that the adhesive stuck to the skin.Customer also reported that the larger of the two catheters seemed to fit the patient better but said that it even came off and also noted that some catheters seemed to be more sticky than others (lot: jufv2649 & lot: jufx2803).
 
Event Description
It was reported that the customer was trying out male external catheters and have tried two types but both were inconsistently staying in place through the night.Customer mentioned that they have stayed on 2 out of 5 nights (lot: jufv2649 & lot: jufx2803).Inquirer reviewed the direction for use with the customer and found that they were appropriately applying the catheter.Customer reported that they cleaned the penis with soap and water, thoroughly dried it and applied the catheter so that it had a limited number of wrinkles and tried to squeeze it so that the adhesive stuck to the skin.Customer also reported that the larger of the two catheters seemed to fit the patient better but said that it even came off and also noted that some catheters seemed to be more sticky than others (lot: jufv2649 & lot: jufx2803).
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "operator error".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: ¿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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13872392
MDR Text Key287805329
Report Number1018233-2022-01523
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070686
UDI-Public(01)00801741070686
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number33103
Device Catalogue Number33103
Device Lot NumberJUFX2803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received05/18/2022
Supplement Dates FDA Received06/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
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
-
-