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

Model Number 36302

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

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 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
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16061092
• MDR Text Key: 306739876
• Report Number: 1018233-2022-09903
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• 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