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

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.

• 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 Key: 13872392
• MDR Text Key: 287805329
• Report Number: 1018233-2022-01523
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070686
• UDI-Public: (01)00801741070686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: 33103
• Device Catalogue Number: 33103
• Device Lot Number: JUFX2803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male