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 2018-11-08 for CYCLESURE? BIO INDICATOR 14324 manufactured by Advanced Sterilization Products.
[126658007]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126658008]
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 chemical indicator (ci) changed color correctly. The previous and subsequent bi results were both negative. The affected load was released and used on two patients. There was no report of infection, injury or harm to the first patient associated with this issue. However, patient #2 reported to have a fever before the operation was performed and still had a fever post-operatively. No additional information is available regarding the patient. Based on the new information received, there is no potential serious injury reported that was related to an asp product. The patient had symptoms before the operation was performed and before the instruments were even used. However, advanced sterilization products (asp) has determined in this situation sterility cannot be assured and, as a matter of policy asp had decided to report all incidents of positive cyclesure? 24 biological indicators when the loads have been released for use without reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2018-00754 |
| MDR Report Key | 8051737 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-08 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2018-11-08 |
| 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? BIO INDICATOR |
| Generic Name | INDICATOR, BIOLOGICAL |
| Product Code | FRC |
| Date Received | 2018-11-08 |
| Catalog Number | 14324 |
| Lot Number | 03218015 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-08 |