Catalog Number 14324 |
Device Problems
Shelf Life Exceeded (1567); Chemical Problem (2893)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14202.Lot number - the correct lot number is 11213-a.Expiration date - the correct expiration date is 02/28/2015.
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Event Description
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A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.The customer stated the expiration date of the product was 02/2015 and was instructed since the product was expired, it should no longer be used.The customer stated the inventory will be checked and expired product will be discarded.The affected load was not released.There is 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® sealsure chemical indicator tape not changing color correctly.
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Manufacturer Narrative
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Method code: actual device not evaluated.Result code: no results available since no evaluation performed.Conclusion code: failure to follow instructions.(b)(4) investigation summary: the investigation included trending of lot number and system risk analysis (sra).Trending analysis by lot number for product codes 'expired product' and 'color-chemical indicator' was reviewed six months prior to complaint open date ((b)(6) 2015 to (b)(6) 2016); trending has not been exceeded for either issue.The sra indicates the risk associated with hazard of 'quality problem with no impact on safety' is "low." the suspect device was not available for product analysis as it was discarded by the customer.Review of the instructions for use (ifu (b)(4)), section 'precaution,' indicates "do not use after expiration date." the customer was advised not to use the product after expiration date.The chemical indicator tape was reported by the customer to be expired at the time of use.This could have been a contributing factor to chemical indicator not changing.An additional potential contributing factor is the customer report of an intermittent vacuum system timeout error with the unit involved.A field service engineer (fse) visited the site to replace the vacuum pump to resolve the issue.A definitive root cause could not be determined for the ci tape issue reported.However, it is not likely the issue was related to the ci tape as trending has not exceeded for this lot.The issue will continue to be tracked and trended.
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Search Alerts/Recalls
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