EMEA CIDEX? OPA SOLUTION 20391

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-02 for EMEA CIDEX? OPA SOLUTION 20391 manufactured by Advanced Sterilization Products.

Event Text Entries

[140681722] Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[140681723] Advanced sterilization products (asp) became aware that a customer was not testing their cidex? Opa solution for the minimum effective concentration (mec) prior to use and their instruments were released for use on patients. The customer stated they change their solution every 14 days as per the instructions for use (ifu) or more frequently depending on use and visual inspection of the solution. The instructions for use (ifu) states the concentration of this product during its reuse life must be verified by the cidex? Opa solution test strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the mec of 0. 3%. The product must be discarded after 14 days, even if the cidex? Opa solution test strip indicates a concentration above the mec. There was no report of injury or harm to patient(s) associated with this issue. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer does not test the cidex? Opa solution with cidex? Opa test strips for the minimum effective concentration (mec) prior to use since asp is not able to guarantee it has been high level disinfected. (b)(4) are related complaints from the same facility. This is two of two 3500a reports being submitted for this product malfunction. Please reference manufacturer report numbers: 2084725-2019-00851 and 2084725-2019-00852.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2084725-2019-00852
MDR Report Key8474713
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-02
Date of Report2019-03-08
Date of Event2019-01-21
Date Mfgr Received2019-05-02
Device Manufacturer Date2018-09-04
Date Added to Maude2019-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. GABRIELA MCLELLAN
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494536396
Manufacturer G1ADVANCED STERILIZATION PRODUCTS
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMEA CIDEX? OPA SOLUTION
Generic NameBIOCIDES SOLUTIONS
Product CodeMED
Date Received2019-04-02
Catalog Number20391
Lot Number050918248
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerADVANCED STERILIZATION PRODUCTS
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-02

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