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

Model Number	33103
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Skin Tears (2516)
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 customer used the ultraflex product, and stated that it removed skin.Per follow up, the customer removed the catheter in the shower, and said there was still glue remaining.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential root cause for this failure could be "electrical failure".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer used the ultraflex product, and stated that it removed skin.Per follow up, the customer removed the catheter in the shower, and said there was still glue remaining.In addition, the customer stated that a different mec fell off.Per follow up via email on 5may2020, the customer stated they had an mec come off when he slept the previous night.

• Brand Name: ULTRAFLEX SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10089759
• Report Number: 1018233-2020-03374
• Device Sequence Number: 11543899
• Product Code: NNX
• UDI-Device Identifier: 00801741070686
• UDI-Public: (01)00801741070686
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 10/28/2024
• Device Model Number: 33103
• Device Catalogue Number: 33103
• Device Lot Number: JUDY2348
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1