MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS; CHEMICAL INDICATOR

Model Number ML02-0118

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer.There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.Medivators fse informed the operators and team leader that the test strips were expired and the facility were going to order new test strips immediately.Rapicide pa test strips instructions for use warns users to not use the strips after the expiration date.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.(b)(4).

Event Description

Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer.There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS
• Type of Device: CHEMICAL INDICATOR
• 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: 7498577
• MDR Text Key: 107730210
• Report Number: 2150060-2018-00037
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 00677964064074
• UDI-Public: 00677964064074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0118
• Device Lot Number: OK157067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other