Model Number US906 |
Device Problem
Unexpected Color (4055)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
malfunction
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Event Description
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It was reported to aesculap inc.That a steam ster locks orange (part # us906) was used to secure a sterilization container.According to the complainant, the indicator dot failed to transition to its post sterilization color.The complaint device has been returned to the manufacturer for evaluation.No patient involvement.
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Manufacturer Narrative
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Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing ten (10) of the locks to steam cycles; a visual examination of the chemical indicator revealed that all dots transitioned from blue to brown.Us906 is assigned a three (3) year expiration.The expiration date reflected on the bag of returned material was 30apr2022.The product was past its expiration when received for complaint investigation testing.Color transition may be less reactive as the indicator nears and passes the end of its lifetime.The color will change from blue to indicate exposure to a steam process, transitioning to a grey/blue color rather than darker brown/charcoal color in this instance.Storage conditions can also affect the final transition color.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The reported event of indicator dot failed to transition properly was not able to be confirmed.Therefore, the most likely root cause was determined to be end user storage conditions or end user equipment.
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Search Alerts/Recalls
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