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 2018-12-11 for CIDEX? OPA SOLUTION 20390 manufactured by Advanced Sterilization Products.
[130316119]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130316120]
A customer reported using expired cidex? Opa solution past the 75-day open date of the bottle and the instruments that were cleaned in the solution were released and used on patients. They stated the solution was tested with the cidex? Opa test strips for the minimum effective concentration (mec) and passed with each use and the solution was heated per instructions for use (ifu) to 20? C (68? F). There was no report of infection, injury or harm to patient(s) associated with this issue. The instructions for use (ifu) states that once the bottle has been opened, the solution remaining in the container may be stored for up to 75 days until used. The customer was advised to always follow the ifu and to discard any solution passed the expiration 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 | 2084725-2018-00780 |
| MDR Report Key | 8151656 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-12-11 |
| 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 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 SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2018-12-11 |
| Catalog Number | 20390 |
| Lot Number | 805000013 |
| 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 | 2018-12-11 |