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.
[72989315]
Brand name - the correct brand name is sterrad? Chemical indicator strip. Catalog number - the correct catalog number is 14100.
Patient Sequence No: 1, Text Type: N, H10
[72989316]
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
[79080875]
Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, and system risk analysis (sra). The dhr was reviewed and all process specifications were met at the time of the release. Trending analysis by lot number was reviewed from 10/15/2016 to 04/13/2017 and trending was not exceeded. The sra indicates the risk associated with a quality problem with no impact on safety is "low. " the product was not returned; therefore, no visual analysis was performed. The fse went onsite and discovered the customer was using older aesculap trays that are known to absorb h2o2. The customer was advised to switch to aptimax trays and the issue has since been resolved. The assignable cause of the issue can be attributed to using older trays that were absorbing h2o2. Customer education was provided and the customer is no longer using the older trays. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2017-00197 |
| MDR Report Key | 6498915 |
| 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 | 2017-05-23 |
| 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 |