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 2017-06-06 for CIDEX OPA SOLUTION TEST STRIPS 20392 manufactured by Advanced Sterilization Products.
[76833876]
Patient Sequence No: 1, Text Type: N, H10
[76833877]
A customer reported using expired cidex? Opa test strips to test the mec (minimum effective concentration) of their cidex? Opa solution and a device/scope that was cleaned and disinfected in the solution was released and used on patients. The customer reported the device/scope was high-level disinfected several times in the solution before realizing their cide? Opa test strips had expired. The hospital stated they were tracking the patients for possible infection. There is no report of any infection or injury as a result of this issue. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer reports using their cidex? Opa test strips past the expiration date on the bottle since high level disinfection cannot be guaranteed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2017-00280 |
| MDR Report Key | 6616655 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-06 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-06-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| 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 TEST STRIPS |
| Generic Name | BIOCIDES TEST STRIPS (JOJ) |
| Product Code | JOJ |
| Date Received | 2017-06-06 |
| Model Number | NA |
| Catalog Number | 20392 |
| ID Number | 20392 |
| 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 | 2017-06-06 |