MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-15 for STERRAD? SEALSURE CHEMICAL INDICATOR TAPE 14202_90 manufactured by Advanced Sterilization Products.
[77720330]
A customer reported using expired sterrad? Chemical indicator tape to process a sterrad? Cycle. The affected load was released and used on patients. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2017-00501 |
| MDR Report Key | 6645766 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-15 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-05-26 |
| Date Mfgr Received | 2017-07-23 |
| Date Added to Maude | 2017-06-15 |
| 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 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 6506874924 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? SEALSURE CHEMICAL INDICATOR TAPE |
| Generic Name | INDICATOR, CHEMICAL |
| Product Code | JOJ |
| Date Received | 2017-06-15 |
| Model Number | NA |
| Catalog Number | 14202_90 |
| 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 IRVINE 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |