MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 2 28MM BX30; MEC SHEATH

Catalog Number 7283

Device Problems Leak/Splash (1354); Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 some of the sheaths stuck so fast, that they struggled to remove them even with the spray and warm water.She was unsure why this happened, but she was uncomfortable using so much of the spray as she was concerned what it would do to the patients' skin.It was also reported that the sheaths were also coming off, and barely lasted half the night.It was unclear if it was because of the amount of urine that was flowing back from the leg bag, and the patient wondered if it could be dissolving the adhesive on the sheaths.

Event Description

It was reported that some of the sheaths stuck so fast, that they struggled to remove them even with the spray and warm water.She was unsure why this happened, but she was uncomfortable using so much of the spray as she was concerned what it would do to the patients' skin.It was also reported that the sheaths were also coming off, and barely lasted half the night.It was unclear if it was because of the amount of urine that was flowing back from the leg bag, and the patient wondered if it could be dissolving the adhesive on the sheaths.

Manufacturer Narrative

The reported event was inconclusive 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 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: "to remove: the sheath may be removed by gently rolling it off the penis.Avoid simply pulling the sheath off.Removing the sheath whilst having a bath or shower may increase comfort." 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.

• Brand Name: ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 2 28MM BX30
• Type of Device: MEC SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9923643
• MDR Text Key: 187538350
• Report Number: 1018233-2020-02358
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071645
• UDI-Public: (01)00801741071645
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7283
• Device Lot Number: JUDX0124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1