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

Model Number 36304

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 02/02/2022

Event Type  malfunction  

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 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.

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 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
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13588209
• MDR Text Key: 290943979
• Report Number: 1018233-2022-00821
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071089
• UDI-Public: (01)00801741071089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Male