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

Model Number 35301

Device Problems Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

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 samples sent were too small and caused some pain; they patient also noted that they were painful to remove.

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 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
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9824720
• MDR Text Key: 185934298
• Report Number: 1018233-2020-01780
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070921
• UDI-Public: (01)00801741070921
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 35301
• Device Catalogue Number: 35301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1