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

Model Number 33301

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

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 catheters were painful to remove from the patient and should come with instructions to trim the area.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.The lot number is unknown; therefore, the device history record could not be reviewed.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.

Event Description

It was reported that the catheters were painful to remove from the patient and should come with instructions to trim the area.

• Brand Name: ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10018221
• MDR Text Key: 189985346
• Report Number: 1018233-2020-02970
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070730
• UDI-Public: (01)00801741070730
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33301
• Device Catalogue Number: 33301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1