CIDEX OPA SOLUTION TEST STRIPS 20392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-06 for CIDEX OPA SOLUTION TEST STRIPS 20392 manufactured by Advanced Sterilization Products.

Event Text Entries

[76833876]
Patient Sequence No: 1, Text Type: N, H10


[76833877] A customer reported using expired cidex? Opa test strips to test the mec (minimum effective concentration) of their cidex? Opa solution and a device/scope that was cleaned and disinfected in the solution was released and used on patients. The customer reported the device/scope was high-level disinfected several times in the solution before realizing their cide? Opa test strips had expired. The hospital stated they were tracking the patients for possible infection. There is no report of any infection or injury as a result of this issue. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer reports using their cidex? Opa test strips past the expiration date on the bottle since high level disinfection cannot be guaranteed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2084725-2017-00280
MDR Report Key6616655
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-06-06
Date of Report2017-05-11
Date of Event2017-05-08
Date Mfgr Received2017-08-22
Date Added to Maude2017-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOAQUIN KURZ
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497893837
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 NameCIDEX OPA SOLUTION TEST STRIPS
Generic NameBIOCIDES TEST STRIPS (JOJ)
Product CodeJOJ
Date Received2017-06-06
Model NumberNA
Catalog Number20392
ID Number20392
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 2017-06-06

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