14100_90

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 2017-05-12 for 14100_90 manufactured by Advanced Sterilization Products.

Event Text Entries

[75099906] Brand name - the correct brand name is sterrad? Chemical indicator strip. Catalog number - the correct catalog number is 14100.
Patient Sequence No: 1, Text Type: N, H10


[75099907] A customer reported a sterrad? Chemical indicator strip did not change color correctly after a completed sterrad? 100s cycle. The affected load was reprocessed. There was no report of infection, injury or harm to patient(s) associated with this issue. Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured. Therefore, as a matter of policy asp had decided to report all incidents of sterrad? Chemical indicator strips not changing color correctly. (b)(4). This is one of two 3500a reports being submitted for this product malfunction. Please reference manufacturer report numbers: 2084725-2017-00232 and 2084725-2017-00233.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2084725-2017-00232
MDR Report Key6565318
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-05-12
Date of Report2017-04-19
Date of Event2017-04-12
Date Mfgr Received2017-06-23
Device Manufacturer Date2016-09-01
Date Added to Maude2017-05-12
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

Generic NameCHEMICAL STERILIZATION PROCESS INDICATOR
Product CodeJOJ
Date Received2017-05-12
Catalog Number14100_90
Lot Number251611-01
ID Number14100-90
Device Expiration Date2018-03-31
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 2017-05-12

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