MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-17 for 14100_90 manufactured by Advanced Sterilization Products.
[73028036]
The correct brand name is sterrad? Chemical indicator strip. The correct catalog number is 14100. The dhr was reviewed and the involved lot met manufacturer specifications at the time of release. No anomalies were observed that would contribute to the customer's experienced issue.
Patient Sequence No: 1, Text Type: N, H10
[73028037]
A customer reported a sterrad? Chemical indicator strip did not change color correctly after a completed sterrad? Nx cycle. The affected load was recalled. There was 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? Chemical indicator strips not changing color correctly.
Patient Sequence No: 1, Text Type: D, B5
[96243341]
Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, visual analysis, retains analysis, concomitant product evaluation, and system risk analysis (sra). The dhr was reviewed and all process specifications were met before the release of the product. Trending analysis by lot number was reviewed from 09/24/2016 to 03/23/2017 and trending was not exceeded. Visual analysis was not performed as the product was not returned for evaluation. Retains testing was not performed since user error was determined to be the cause. The concomitant sterrad? Nx was tested by an asp field service engineer (fse). Upon arrival, the fse confirmed the customer was using aesculap pans which are known to absorb h2o2 as they age and was advised to switch to aptimax trays instead. The issue has since resolved. The sra indicates the risk associated with a quality problem with no impact on safety is "low. " the assignable cause of the issue can be attributed to using aged aesculap trays. The fse provided customer education regarding the trays and the issue has since been resolved. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2017-00193 |
| MDR Report Key | 6498840 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-01-15 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CHEMICAL STERILIZATION PROCESS INDICATOR |
| Product Code | JOJ |
| Date Received | 2017-04-17 |
| Catalog Number | 14100_90 |
| Lot Number | 251611-02 |
| ID Number | 14100-90 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |