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 2017-08-16 for STERRAD? CHEMICAL INDICATOR STRIP 14100 manufactured by Advanced Sterilization Products.
[82791567]
(b)(4). (b)(6). Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, retains testing, concomitant product evaluation, visual analysis and system risk analysis (sra). ? 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 11/22/2016 to 5/22/2017 and no significant trend is observed. ? Thirty retains ci stips were subject to functional evaluation. All thirty ci strips met specification for color change post-sterrad? Processing. ? Concomitant product evaluation determined it is unlikely that the sterrad? 100s unit contributed to the issue since the cycle completed and the remainder of the ci strip changed color correctly. ? The product was not returned; however, visual analysis was performed from a photograph of the affected product provided by the customer. The picture confirms there is a "red spot" on the strip and the remainder of the strip has changed color correctly. It could not be determined if the red spot was a result of the ci strip being blocked during sterilization and the customer was unable to confirm if that was the situation or not. ? The sra indicates the risk associated with a exposure to biohazardous, pathogenic or infectious material is "low. " there is insufficient information to determine an assignable cause. It is unlikely that the color-chemical indicator issue was caused by a manufacturing issue since the retains product met functional specification, dhr review found no anomalies that would contribute to a incorrect color change and no significant trends were found in lot trending review. An issue with sterrad? Performance is also unlikely since the cycle passed and the remainder of the ci strip changed color correctly. The chemical indicator retains met functional specification. As a result, there is not an issue with product performance when used per the instructions for use (ifu). The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
[82791568]
A customer reported a sterrad? Chemical indicator strip did not change color correctly after a completed sterrad? 100s cycle. The affected load was released for use 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. Therefore, as a matter of policy asp had decided to report all incidents of sterrad? Chemical indicator strips not changing color correctly and the load is released without reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2017-00535 |
| MDR Report Key | 6797480 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-16 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2016-08-08 |
| Date Added to Maude | 2017-08-16 |
| 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 |
| Manufacturer Phone | 949789-383 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? CHEMICAL INDICATOR STRIP |
| Generic Name | CHEMICAL INDICATOR |
| Product Code | JOJ |
| Date Received | 2017-08-16 |
| Catalog Number | 14100 |
| Lot Number | 221611-02 |
| Device Expiration Date | 2018-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-08-16 |