MAUDE Adverse Event Report: MEDIVATORS INC. RAPICIDE PA HIGH-LEVEL DISINFECTANT; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number ML02-0117

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Viewed box that arrived with a capless bottle of rapicide that had spilled into box.Cap visible at bottom of box.Box with visible damage, wetness.Surprised to see that the bottles of rapicide have a simple cap (no safety features) and the bottles have no seal under the cap or other anchor/seal to minimize chance for leakage or loss of cap en route.Staff noted that when they open the boxes of rapicide they never removes the bottles from the box without tightening them first as they are often loose.This has happened at another facility as well.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 10331894
• MDR Text Key: 200625742
• Report Number: 10331894
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ML02-0117
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1