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

Model Number	36302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
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 customer stated that the adhesive strength of the condom urinals adhere only briefly and slip off with every movement.Per follow-up information received via ibc on (b)(6) 2022, stated that the patient complains about the adhesion and the length of the wearing time to insufficient adhesion.Also stated that there is no information on the connection with a urine bag.Based on sample evaluation received on 12dec2022 it was stated that strong adhesion was found in male external catheter.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related as high adhesive was found in the evaluated representative sample and the condition of the original used sample was unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review was not required as labelling would not have prevented the reported event.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the customer stated that the adhesive strength of the condom urinals adhere only briefly and slip off with every movement.Per follow-up information received via ibc on 30nov2022, stated that the patient complains about the adhesion and the length of the wearing time to insufficient adhesion.Also stated that there is no information on the connection with a urine bag.Based on sample evaluation received on 12dec2022, stated that strong adhesion was found in male external catheter.

• Brand Name: WIDEBAND¿ 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: 16061092
• Report Number: 1018233-2022-09903
• Device Sequence Number: 11273888
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 36302
• Device Catalogue Number: 36302
• Device Lot Number: JUFW9230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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: Unknown