MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 1 32MM BX30; MEC

Catalog Number	5323
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)
Date of Event	04/16/2018
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the sheaths were covered in too much adhesive so much so they are difficult to remove and are causing damage to the patient's skin on legs where they touch the adhesive.It gets on the patients clothing and they are much more difficult to unroll.Per additional information the skin was not damaged.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "not made with natural rubber latex non sterile fitting the sheath the sheath is a strapless penile sheath: it has an adhesive coating inside to ensure a safe and simple procedure for fitting.-if necessary trim pubic hair.-clean and dry pubic area.-remove sheath from its wrapping -place rolled end over the end of the penis, leaving a small space between the end of the penis and the cup of the sheath.If uncircumcised do not retract the foreskin but allow it to remain over the glans.Avoid contact between the adhesive and the glans.-slowly unroll the sheath along the shaft of the penis, then gently squeeze the sheath around the penis to ensure even adhesion, try to avoid leaving a rolled ¿collar¿ of sheath around the base of the penis.-finally connect the urine collection bag.Always check that the connections are secure before use.-wear time will vary from user to user.It is recommended that the sheath be changed every 24 hours for reasons of hygiene.-to remove: the sheath may be removed gently it off the penis.Avoid simply pulling the sheath off.Removing the sheath whilst having a bath or shower may increase comfort.Do not use on irritated or compromised skin.Discontinue use if irritation occurs.".
Event or Problem Description
It was reported that the sheaths were covered in too much adhesive so much so they were difficult to remove and have caused damage to the patient's skin on the legs where they touch the adhesive; which have gotten on the patients clothing and have been much more difficult to unroll.Per additional information the skin was not damaged.

• Brand Name: ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 1 32MM BX30
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7502651
• Report Number: 1018233-2018-01612
• Device Sequence Number: 1862361
• Product Code: NNX
• UDI-Device Identifier: 00801741071584
• UDI-Public: (01)00801741071584
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 09/28/2022
• Device Catalogue Number: 5323
• Device Lot Number: JUBX0198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1