Catalog Number 10144 |
Device Problems
Leak/Splash (1354); Device Handling Problem (3265)
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Patient Problem
Skin Burning Sensation (4540)
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Event Date 11/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone number: (b)(6).The hcw was re-trained to always wear personal protective equipment (ppe) when handling cassettes.The batch record review did not reveal any indication on a deviating quality profile for this batch.A visual analysis on the field sample picture and the retain samples was performed.The picture showed a cell with lower filling volume.The retain samples of the finished good and the intermediate batch did not show leakage or any other kind of damage.The rfid label check was successful; the cassette is considered within specification.It was confirmed that the cell appears to have a lower fill volume; however, leakage cannot be determined from the picture as it is unknown if loss of volume occurred before or after the opening of the package, and since the indicator strip did not change color to indicate leakage.Asp complaint ref #: (b)(4).
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Event Description
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A customer reported an event of a leak for the sterrad® 100nx cassette without the leak chemical indicator strip changing color.A healthcare worker (hcw), who was not wearing gloves, made skin contact with the hydrogen peroxide when opening the cassette package and experienced ¿burned¿ finger.The hcw washed with plenty of water and did not receive medical treatment for the skin reaction.Lastly, the symptoms lasted one day and the hcw has recovered.The h2o2 skin reaction resolved without medical treatment and is not considered a serious injury; however, this event is being reported as a malfunction report subsequent to a serious injury.
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Manufacturer Narrative
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H3: asp investigation summary: the investigation included a review of the device batch record, retains testing of lot, trending analysis by lot number, and system risk analysis (sra).Retains testing was completed with no issues identified.All in-process controls are within specifications.Trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the product was not available for further evaluation.The assignable cause for the sterrad 100nx cassette leakage could not be verified.The batch record review did not identify a contributing factor for this reported issue as all cellblocks undergo 100% check for leakages (vacuum test) after production.The most likely assignable cause for the h2o2 skin reaction was failure to follow the sterrad 100nx cassette ifu in wearing personal protective equipment when handling cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
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Search Alerts/Recalls
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