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 2019-03-15 for DISOPA? SOLUTION 17800 manufactured by Advanced Sterilization Products.
[138965538]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138965539]
A customer initially reported? Foreign matter? Or precipitate with their disopa solution after use. After follow-up with the customer, it was confirmed they are thoroughly pre-cleaning and rinsing their devices prior to immersing them into the disopa solution. In addition, the customer stated they are not testing their solution for the minimum effective concentration (mec) prior to use. They stated they pour the solution into a container and discard the solution after 14-days of use. The instructions for use (ifu) states the concentration of this product during its reuse life must be verified by the disopa 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 infection, 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 disopa solution with disopa test strips for the minimum effective concentration (mec) prior to use since asp is not able to guarantee it has been high level disinfected. The customer was since been retrained to always follow the instructions for use (ifu).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-00838 |
| MDR Report Key | 8425693 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-15 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-05-22 |
| Device Manufacturer Date | 2018-09-23 |
| Date Added to Maude | 2019-03-15 |
| 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. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949453-639 |
| 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 | DISOPA? SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2019-03-15 |
| Catalog Number | 17800 |
| Lot Number | F000028143 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-15 |