Catalog Number 14324 |
Device Problem
Chemical Problem (2893)
|
Patient Problem
No Information (3190)
|
Event Date 10/14/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The customer reported the sterrad sealsure chemical indicator tape did not change color correctly after a completed sterrad cycle.It is unknown if the affected load was recalled or released for use.It is unknown if there is any 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.
|
|
Manufacturer Narrative
|
Asp investigation summary: the investigation included a review of the device history record (dhr), lot trending and system risk analysis (sra).¿ the dhr could not be reviewed as the lot number was not provided.¿ the sra indicates the risk associated with a quality problem with no impact to safety is "low." ¿ trending by lot number was not performed as the lot number was not provided.The product was not returned; therefore, no visual analysis was performed.There is insufficient information to determine an assignable cause of the issue.Several attempts for additional information were unsuccessful.The issue will continue to be tracked and trended.
|
|
Search Alerts/Recalls
|