MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 25MM 30BX

Model Number	35301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199)
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 the samples sent were too small and caused some pain; they patient also noted that they were painful to remove.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "operator error".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: "directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".
Event or Problem Description
It was reported that the samples sent were too small and caused some pain; they patient also noted that they were painful to remove.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 25MM 30BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9824720
• Report Number: 1018233-2020-01780
• Device Sequence Number: 2814872
• Product Code: NNX
• UDI-Device Identifier: 00801741070921
• UDI-Public: (01)00801741070921
• 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): 04/09/2020

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: Lay User/Patient
• Device Model Number: 35301
• Device Catalogue Number: 35301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1