MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX

Catalog Number 39303

Device Problems Nonstandard Device (1420); Defective Device (2588)

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 the patient's daughter called, as they had been using the sheath 3323, and the most recent box they received had too much glue.Due to having too much glue, they were unable to remove them.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿device is difficult to remove¿.A potential root cause for this failure could be "adhesive is too strong".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: "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 a sheath be changed every 24 hours for reasons of hygiene.To remove: the sheath may be removed by gently rolling it on the penis.Avoid simply pulling the sheath.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." 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient's daughter called, as they had been using the sheath 3323, and the most recent box they received had too much glue.Due to having too much glue, they were unable to remove them.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9254846
• MDR Text Key: 177245487
• Report Number: 1018233-2019-06921
• Device Sequence Number: 1
• Product Code: NNX
• 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: 10/30/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 39303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1