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 2017-06-01 for CIDEX OPA SOLUTION TEST STRIPS 20392 manufactured by Advanced Sterilization Products.
[76522619]
Catalog number - the correct catalog number is 20392_03. Asp investigation summary: the investigation included a review of the batch history record, complaint trending, risk analysis per based on standard hazard list review and supplier analysis. The batch history record indicates that the product met all specifications in accordance to asp's quality requirements at the time of release. Trending analysis by lot number was reviewed from 11/05/2016 to 05/04/2017 and trending was not exceeded. The system hazards list indicates the risk associated with exposure to toxic or corrosive material (exposure only) is "low. " the supplier was not notified as the issue was not identified as a manufacturing or functional issue. The assignable cause for the reported expired product is identified to be due to customer mis-use; the customer advised that the expiration date was not verified prior to processing. The applicable instructions for use (ifu) and a letter will be sent to the customer referring to the ifu for instructions. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
[76522620]
A customer reported using their cidex? Opa test strips after the expiration date on the outside of the bottle and nine loads were released and used on patients. No harm or injury has been reported with any patient(s), and the customer confirmed the facility policy will be followed for patient notification. 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 | 2084725-2017-00268 |
| MDR Report Key | 6603977 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-01 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2017-06-01 |
| 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 | 2017-06-01 |
| Model Number | NA |
| Catalog Number | 20392 |
| Lot Number | 029120 |
| ID Number | 20392 |
| Device Expiration Date | 2017-03-28 |
| 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 | 2017-06-01 |