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 2018-11-14 for CYCLESURE? 24 BIO INDICATOR 14324 manufactured by Advanced Sterilization Products.
[128444876]
(b)(4). Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis. The dhr was reviewed and the involved lot met manufacturer specifications at the time of release. No anomalies were observed that would contribute to the customer's experienced issue. Trending analysis by lot number was reviewed from 02/14/2018 to 08/15/2018 and trending was not exceeded. The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low. " the single cyclesure? 24 bi was not returned for visual inspection. The biological has since expired. Therefore, retains testing could not be performed. The customer was unresponsive to requests for additional information regarding the issue. Therefore, there is insufficient information to determine an assignable cause. It is unlikely the suspected positive bi was caused by a performance issue since dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot. The issue will continue to be tracked and trended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128444877]
A customer reported a positive result with a cyclesure? 24 biological indicator (bi) after a completed sterrad? Nx cycle. The bi was incubated for 24 hours. The affected load was released and used on a patient. 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 positive 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 | 2084725-2018-00761 |
| MDR Report Key | 8069624 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2017-10-27 |
| Date Added to Maude | 2018-11-14 |
| 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 | 2018-11-14 |
| Catalog Number | 14324 |
| Lot Number | 30017279 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2018-11-14 |