RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS ML02-0118

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-09 for RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS ML02-0118 manufactured by Medivators.

Event Text Entries

[107730210] 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).
Patient Sequence No: 1, Text Type: N, H10


[107730211] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2150060-2018-00037
MDR Report Key7498577
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-05-09
Date of Report2018-05-09
Date of Event2018-04-11
Date Mfgr Received2018-04-11
Device Manufacturer Date2015-02-01
Date Added to Maude2018-05-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALEX NELSON
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer Phone7635094799
Manufacturer G1MEDIVATORS
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS
Generic NameCHEMICAL INDICATOR
Product CodeJOJ
Date Received2018-05-09
Model NumberML02-0118
Lot NumberOK157067
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDIVATORS
Manufacturer Address14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-09

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