MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 29MM 30BX

Model Number	37302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not 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: "1)wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.".
Event or Problem Description
It was reported that the male external catheter had too much adhesive.
Additional Manufacturer Narrative
The device was not 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: "1)wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.".
Event or Problem Description
It was reported that the male external catheter had too much adhesive.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 29MM 30BX
• Common Device Name: MEC SPIRIT SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9378568
• Report Number: 1018233-2019-07550
• Device Sequence Number: 13576123
• Product Code: NNX
• UDI-Device Identifier: 00801741071188
• UDI-Public: (01)00801741071188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 37302
• Device Catalogue Number: 37302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1