MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-02 for EMEA CIDEX? OPA SOLUTION 20391 manufactured by Advanced Sterilization Products.
[140682531]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140682532]
Advanced sterilization products (asp) became aware that a customer was not testing their cidex? Opa solution for the minimum effective concentration (mec) prior to use and their instruments were released for use on patients. The customer stated they change their solution every 14 days as per the instructions for use (ifu) or more frequently depending on use and visual inspection of the solution. The instructions for use (ifu) states the concentration of this product during its reuse life must be verified by the cidex? Opa solution test strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the mec of 0. 3%. The product must be discarded after 14 days, even if the cidex? Opa solution test strip indicates a concentration above the mec. There was no report of injury or harm to patient(s) associated with this issue. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer does not test the cidex? Opa solution with cidex? Opa test strips for the minimum effective concentration (mec) prior to use since asp is not able to guarantee it has been high level disinfected. (b)(4) are related complaints from the same facility. This is one of two 3500a reports being submitted for this product malfunction. Please reference manufacturer report numbers: 2084725-2019-00853 and 2084725-2019-00852.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-00853 |
| MDR Report Key | 8475013 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2018-09-04 |
| Date Added to Maude | 2019-04-02 |
| 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 | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494536396 |
| 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 | EMEA CIDEX? OPA SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2019-04-02 |
| Catalog Number | 20391 |
| Lot Number | 050918248 |
| 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 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |