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

Model Number	33103
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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).
Additional 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 or Problem 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).
Additional 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: ''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 warmwater.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." the device was not returned.

• Brand Name: ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: 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: 13873490
• Report Number: 1018233-2022-01535
• Device Sequence Number: 5296226
• Product Code: NNX
• UDI-Device Identifier: 00801741070686
• UDI-Public: (01)00801741070686
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2026
• Device Model Number: 33103
• Device Catalogue Number: 33104
• Device Lot Number: JUFV2649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male