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 2018-11-16 for CIDEX? OPA TEST STRIPS 20392 manufactured by Advanced Sterilization Products.
[129158586]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129158587]
A customer reported using expired cidex? Opa test strips to test their cidex? Opa solution and the instruments that were cleaned in the tested cidex? Opa solution were released and used on patients. They stated they used the test strips because the instructions for use (ifu) states the strips can be used for 90-days after opening the bottle, and the cidex? Opa strips came out positive (or purple) indicating the cidex? Opa solution meets the minimum effective concentration (mec). There was no report of infection, injury or harm to patient(s) associated with this issue. The customer was advised to discard any remaining cidex? Opa test strips and to follow the instructions for use (ifu) which states the unused cidex? Opa test strips should be discarded after the expiration date on the outside of the bottle even if it has not reached the 90-day open date. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer uses expired product and releases it for use on patients since they cannot guarantee high-level disinfection has been achieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2018-00763 |
| MDR Report Key | 8078374 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2017-10-01 |
| Date Added to Maude | 2018-11-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| 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 |
| Brand Name | CIDEX? OPA TEST STRIPS |
| Generic Name | BIOCIDES TEST STRIPS |
| Product Code | JOJ |
| Date Received | 2018-11-16 |
| Catalog Number | 20392 |
| Lot Number | 031779 |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-16 |