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 2020-03-10 for CIDEX? OPA SOLUTION 20390 manufactured by Advanced Sterilization Products.
[186101309]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186101310]
A customer reported using cidex? Opa solution past the 14-day reuse date and the instruments were released and used on patients. The customer stated the solution was tested prior to use and met the minimum effective concentration (mec). There were no reports of any injury, harm or infections reported. Per the instructions for use (ifu), cidex? Opa solution may be reused for up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the directions for use. Do not rely solely on days in use. 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. Although there is no patient harm or injury reported, advanced sterilization products has decided to report cases when the customer uses expired product and releases the instruments for use since high-level disinfection cannot be assured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-50028 |
| MDR Report Key | 9812390 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2020-03-10 |
| 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 | GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495030264 |
| Manufacturer G1 | ASP IRVINE MFG |
| 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 (MED) |
| Product Code | MED |
| Date Received | 2020-03-10 |
| Catalog Number | 20390 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |