MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC ULTRAFLEX M 30BX; MALE EXTERNAL CATHETER

Model Number 33302

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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 male external catheter had strong adhesive.The catheter reportedly had to be pulled up and cut in order for it to be removed.

Manufacturer Narrative

The reported event could not be confirmed due to the condition of the sample.Visual inspection noted one male external catheter was received.Visual evaluation noted the device was used and cut into pieces on return.The results of this investigation were inconclusive due to poor sample condition.A potential root cause for this failure could be mechanical 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.

Event Description

It was reported that the male external catheter had strong adhesive.The catheter reportedly had to be pulled up and cut in order for it to be removed.

• Brand Name: ROCHESTER MEC ULTRAFLEX M 30BX
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9559842
• MDR Text Key: 179251862
• Report Number: 1018233-2020-00165
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 33302
• Device Catalogue Number: 33302
• Device Lot Number: JUDQ0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1