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 2017-09-22 for CIDEX? OPA SOLUTION TEST STRIPS 20392 manufactured by Advanced Sterilization Products.
[87881081]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87881082]
A customer reported using expired cidex? Opa test strips to test the mec (minimum effective concentration) of their cidex? Opa solution and the devices/scopes that were cleaned and disinfected in the solution were released and used on patient(s). 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 | 2084725-2017-00580 |
| MDR Report Key | 6887438 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-11-03 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-09-22 |
| 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 | MR. JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| 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 |
| Product Code | JOJ |
| Date Received | 2017-09-22 |
| Catalog Number | 20392 |
| Lot Number | 029814 |
| Device Expiration Date | 2017-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-22 |