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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX Back to Search Results
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.
 
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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 Key9254846
MDR Text Key177245487
Report Number1018233-2019-06921
Device Sequence Number1
Product Code NNX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number39303
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/07/2019
Initial Date FDA Received10/30/2019
Supplement Dates Manufacturer Received10/29/2019
Supplement Dates FDA Received10/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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