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 2019-01-08 for CYCLESURE? 24 BIO INDICATOR 14324 manufactured by Advanced Sterilization Products.
[132567597]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132567598]
A customer reported a (b)(6) result with a cyclesure 24 biological indicator (bi) after a completed sterrad 100s cycle. The bi was incubated for 24 hours. The affected load was released and used on a patient. The chemical indicator (ci) changed color correctly. The previous and subsequent bi results were both negative. There was no report of infection, injury or harm to patient(s) associated with this issue. Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured. Therefore, as a matter of policy asp had decided to report all incidents of (b)(6) cyclesure 24 biological indicators when the load has been released and used on patient(s) prior to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-00796 |
| MDR Report Key | 8227447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-25 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-01-08 |
| 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. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| 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 | CYCLESURE? 24 BIO INDICATOR |
| Generic Name | INDICATOR, BIOLOGICAL |
| Product Code | FRC |
| Date Received | 2019-01-08 |
| Catalog Number | 14324 |
| Lot Number | 21318072 |
| 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 | 2019-01-08 |