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 2018-01-24 for STERRAD? SEALSURE? CI TAPE 14202 manufactured by Advanced Sterilization Products.
[98189477]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98189478]
A customer reported the sterrad sealsure chemical indicator tape did not change color correctly after a completed sterrad 100s cycle, and the load was released for use on patients prior to reprocessing. There is 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 sterrad sealsure chemical indicator tape not changing color correctly when the load is released for use prior to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2018-00516 |
| MDR Report Key | 7217200 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-10 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2016-09-21 |
| Date Added to Maude | 2018-01-24 |
| 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 Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ASP IRVINE MFG |
| 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 | STERRAD? SEALSURE? CI TAPE |
| Generic Name | INDICATOR, CHEMICAL |
| Product Code | JOJ |
| Date Received | 2018-01-24 |
| Catalog Number | 14202 |
| Lot Number | 24916 |
| Device Expiration Date | 2018-07-21 |
| 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 DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-24 |