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 2017-04-17 for 14100_90 manufactured by Advanced Sterilization Products.

Event Text Entries

[73101031] 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


[73101032] A customer reported a sterrad? Chemical indicator strip did not change color correctly after a completed sterrad? Nx cycle. The affected load was recalled. 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.
Patient Sequence No: 1, Text Type: D, B5


[87031006] Asp investigation summary: the investigation included a review of the device history record (dhr), retains analysis, trending of lot number, visual analysis, concomitant product evaluation and system risk analysis (sra). ? The dhr, retains testing, trending analysis by lot number were not reviewed since the lot number was not available. ? The concomitant sterrad nx was tested by an asp field service engineer (fse). The fse confirmed the customer was using older aesculap pans which are known to absorb h2o2 as they age. The customer was advised to switch to using aptimax trays instead. The issue was resolved since the customer began using other trays. ? The sra indicates the risk associated with a quality problem with no impact on safety is "low. "? The product was not returned; therefore, no visual analysis was performed. The assignable cause of the issue can be attributed to using aging aesculap trays. The fse advised the customer to switch to other trays and the issue resolved. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2084725-2017-00196
MDR Report Key6498891
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-04-17
Date of Report2017-03-23
Date of Event2017-01-15
Date Mfgr Received2017-06-13
Date Added to Maude2017-04-17
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 Received2017-04-17
Catalog Number14100_90
Lot NumberUNK
ID Number14100-90
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 2017-04-17

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