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

Model Number	33104
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient had difficulties with male external catheter.Stated that when the patient urinates, the urine stayed inside the tip of the catheter and would not flow down the tubing and into the band and caused leakage and said it seemed like there was a pocket of air and the urine would not flow.Inquirer confirmed that the patient had been connecting the bag and tubing to the male external catheter prior to placing the catheter on the penis and it did not feel like the patient got a good grip from the adhesive on the catheter and also discussed ways to prevent air lock, put the catheter on first then connected the tubing or bag to the tip and exercising the bag prior use.
Additional Manufacturer Narrative
The reported issue was confirmed as use related issue as per the reported event and instructions for use.A potential root cause for this failure could be due to ¿user deviation from ifu".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: "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." 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.
Event or Problem Description
It was reported that the patient had difficulties with male external catheter.Stated that when the patient urinates, the urine stayed inside the tip of the catheter and would not flow down the tubing and into the band and caused leakage and said it seemed like there was a pocket of air and the urine would not flow.Inquirer confirmed that the patient had been connecting the bag and tubing to the male external catheter prior to placing the catheter on the penis and it did not feel like the patient got a good grip from the adhesive on the catheter and also discussed ways to prevent air lock, put the catheter on first then connected the tubing or bag to the tip and exercising the bag prior use.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15208874
• Report Number: 1018233-2022-06284
• Device Sequence Number: 14652641
• Product Code: NNX
• UDI-Device Identifier: 00801741070693
• UDI-Public: (01)00801741070693
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/08/2022

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 Model Number: 33104
• Device Catalogue Number: 33104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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