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 2019-03-29 for STERRAD? SEALSURE CI TAPE 14202 manufactured by Advanced Sterilization Products.
[140325852]
Asp investigation summary: the investigation included a review of the device history record, trending analysis by lot number, system risk analysis (sra) and supplier product investigation. The device history record was reviewed and process specifications for product release were met. No issues were observed that would contribute to the complaint. Trending analysis by lot number was reviewed from 2/6/2018 to 8/6/2018 and no significant trend was observed. The sra indicates the risk associated with exposure to toxic or corrosive material is "low. ". One sterrad? Sealsure ci tape retains of the same lot was subject to functional investigation by the supplier. A sterilization test was performed and the color of the ci tape changed normally from red to yellow. The assignable cause of the issue could not be confirmed; however, a likely cause could be due to the customer's load contents as subsequent use of the sealsure chemical indicator tape provided acceptable results according to the customer. Also, the supplier could not replicate the issue with the retain sample. The issue will continue to be tracked and trended. (b)(6). Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140325853]
A customer initially reported the sterrad? Sealsure chemical indicator tape did not change color correctly after a completed sterrad? 100s cycle. At the time of the report, it was unknown whether or not the affected load was released for use on patients prior to reprocessing. Upon follow-up with the customer on (b)(6) 2019, it was determined the load was released for use without reprocessing first. 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 without reprocessing first.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-00846 |
| MDR Report Key | 8464847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2019-03-29 |
| 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 | STERRAD? SEALSURE CI TAPE |
| Generic Name | INDICATOR, CHEMICAL |
| Product Code | FRC |
| Date Received | 2019-03-29 |
| Catalog Number | 14202 |
| Lot Number | 34817 |
| 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 | 2019-03-29 |