|
Catalog Number 43210 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/08/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The batch history record was reviewed; no non-conformances were identified, and no anomalies were observed that would contribute to the reported issue.The reported lot number met manufacturer specifications at the time of release.Asp complaint ref #: cmp-(b)(4).
|
|
Event Description
|
A customer reported a positive result with a sterrad velocity¿ biological indicator (bi) after a completed sterrad® nx cycle.The affected load was released and used on a patient.There was no report of infection, injury or harm to patient(s) associated with this issue.Although there was 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 positive sterrad velocity¿ biological indicators when the load has been released and used on patient(s) prior to reprocessing.
|
|
Manufacturer Narrative
|
H3: asp investigation summary: the investigation included a review of the batch history record, trending analysis of the lot number, system risk analysis (sra), and retains testing.¿ trending analysis by lot number was reviewed from bi manufacture date to complaint open date and trending was not exceeded.¿ review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.The single sterrad velocity¿ bi was not returned for evaluation, and therefore, visual analysis could not be performed.The assignable cause of the suspected positive bi could not be verified.The batch history record review found no anomalies that would contribute to the complaint issue and retains testing met specification.However, the product was not returned so no further analysis could be performed.The customer was advised to follow their facility policies and procedures regarding the released load.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
|
|
Search Alerts/Recalls
|
|
|