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

Device Problem Nonstandard Device (1420)

Patient Problem Skin Tears (2516)

Event Date 05/10/2022

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 customer wanted to know if any other male external catheter besides the ones with adhesive and the one without adhesive that comes with the foam strap.It was stated that the customer used male external catheter before, and the adhesive was too strong, and it has removed skins when taking off and left penis raw.Inquirer discussed the methods for removal that would assist with adhesive breakdown and hopefully prevent any damage such as warm wet compresses and adhesive removers.Also discussed mcguire style male urinal that is designed with jock strap and soft latex sheath that snaps off and on.It would be washed and reused and connects to leg bags.No medical intervention was reported.

Manufacturer Narrative

The reported issue was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be ¿mechanical failure".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.The device was not returned.

Event Description

It was reported that the customer wanted to know if any other male external catheter besides the ones with adhesive and the one without adhesive that comes with the foam strap.It was stated that the customer used a male external catheter before, and the adhesive was too strong, and it has removed skins when taking off and left the penis raw.Inquirer discussed the methods for removal that would assist with adhesive breakdown and hopefully prevent any damage, such as warm wet compresses and adhesive removers.Also discussed, mcguire style male urinal that is designed with jock strap and soft latex sheath that snaps off and on.It would be washed and reused and connects to leg bags.No medical intervention was reported.

• Brand Name: 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: 14526900
• MDR Text Key: 293072044
• Report Number: 1018233-2022-04197
• Device Sequence Number: 1
• Product Code: NNX
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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