MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT

Model Number ML02-0117

Device Problems Fluid/Blood Leak (1250); Shipping Damage or Problem (1570); Chemical Spillage (2894)

Patient Problems Headache (1880); Nausea (1970); Chemical Exposure (2570)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported 2 leaking cases of rapicide pa high level disinfectant when a shipment of 6 cases was brought in to the facility's holding room.The 2 cases that were leaking were reported to be on their side when the carrier brought them in to the facility.It was reported that 5-6 people experienced chemical exposure symptoms from the leak including headache and nausea.Medivators regulatory affairs has made several attempts to contact the initial reporter with no success.The current condition of the exposed people is unknown.The orientation of the box containing the hld is required to be upright and it is unknown when they were placed on their side.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported 2 leaking cases of rapicide pa high level disinfectant when a shipment was brought into the facility's holding room.According to the report, 5-6 people experienced chemical exposure symptoms including nausea and headache.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7160723
• MDR Text Key: 96335463
• Report Number: 2150060-2018-00001
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/14/2019
• Device Model Number: ML02-0117
• Device Lot Number: 885122|P|01
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other