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
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 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 or Problem 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.
Additional 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
• Common Device Name: MEC SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9923643
• Report Number: 1018233-2020-02358
• Device Sequence Number: 19535183
• Product Code: NNX
• UDI-Device Identifier: 00801741071645
• UDI-Public: (01)00801741071645
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 7283
• Device Lot Number: JUDX0124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/12/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1