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

Model Number	33302
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
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 catheters were causing leakage and a possible urinary tract infection.Unknown what medical intervention was provided for the urinary tract infection.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the catheters were causing leakage and a possible urinary tract infection.Unknown what medical intervention was provided for the urinary tract infection.Per follow up call on 22oct2021, customer stated that the catheters would loose grip and slip down and would stick themselves at the head of the penis.The urine would collect at the end of the catheter instead of moving into the hose of the leg bag.Customer had changed back to the natural catheter.Stated that customer had experienced rash and redness which was a self-made tourniquet from the velcro straps of a leg bag.Customer was using the tourniquet to prevent the head of his penis from retracting into the shaft.The rash was a result of the velcro rubbing on his skin.It was also reported that the customer had urinary tract infection with prescription medication from physician related to urine building up at the tip of penis.The urinary tract infection was about two weeks ago, and the latest doctor¿s appointment indicated the customer was well.Customer also suggested an air release valve be added to the tubing so that it could be released causing air to push the urine towards the bag and preventing urine from gathering at the tip of the penis.

• 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: 12584714
• Report Number: 1018233-2021-06261
• Device Sequence Number: 3920937
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 33302
• Device Catalogue Number: 33302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 01/28/2022
• 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