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

Model Number	36304
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Pain (1994); Skin Tears (2516)
Date of Event	02/02/2022
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.The device was not returned.
Event or Problem Description
It was reported that the male external catheter adhesive was very sticky and almost painful to the patient.Patient wanted to know if the liberator representative had any less adhesive catheters.Patient stated that they attempted to use one but would keep the other four.Patient had been using the products for less than 90 days.No medical intervention was reported.Per additional information received on 07feb2022, it was stated that the adhesive was too strong which made difficult to remove the catheters without tearing the skin.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.The device was not returned.
Event or Problem Description
It was reported that the male external catheter adhesive was very sticky and almost painful to the patient.Patient wanted to know if the liberator representative had any less adhesive catheters.Patient stated that they attempted to use one but would keep the other four.Patient had been using the products for less than 90 days.No medical intervention was reported.Per additional information received on 07feb2022, it was stated that the adhesive was too strong which made difficult to remove the catheters without tearing the skin.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13588209
• Report Number: 1018233-2022-00821
• Device Sequence Number: 4118488
• Product Code: NNX
• UDI-Device Identifier: 00801741071089
• UDI-Public: (01)00801741071089
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 36304
• Device Catalogue Number: 36304
• Device Lot Number: JUFZ9056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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