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 2020-02-21 for VELOCITY? 30 BIOLOGICAL INDICATOR 43210-30 4321030 manufactured by Advanced Sterilization Products.
[185500789]
Concomitant med products: sterrad 100nx sterilizer, serial # (b)(4). (b)(4). Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis, and unused product evaluation. 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 08/06/2019 to 11/13/2019 and trending was not exceeded. The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low. " the single velocity? Bi was returned for visual inspection. The chemical indicator disc was yellow in color, the cap was depressed and no media was observed. The reported issue was not confirmed. Thirteen (13) unused bis were submitted for functional evaluation. Eleven bi's were tested and two bi's were used as controls. Functional specification was met with 0+/11 bis. The media level of all 13 samples were visually inspected both pre and post processing and no change in media level was observed. The assignable cause could not be confirmed. It is unlikely the suspected positive bi was caused by a manufacturing issue as the unused product functional evaluation met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot. Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result. An issue with sterrad? Performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly. In regards to the released load, the customer was advised to always follow the instructions for use which state: a positive result on a test bi signifies that a sterilization condition was not achieved. If a positive result is observed: follow the current hospital or healthcare facility? S policies and procedures regarding quarantine, or retrieval, and reprocessing of potentially non-sterile instruments and notification of the physician(s). The issue will continue to be tracked and trended. Asp complaint ref: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185500790]
A customer reported a positive result with a velocity? Biological indicator (bi) after a completed sterrad? 100nx cycle. The bi was incubated for 30 minutes. The bi was processed on the bottom shelf close to the rear of the chamber, and the bi was not placed in the pouch with the load or secured to the load using tape. The result of the previous and subsequent two bis were negative. No tape/labeling was placed over the cap holes prior to processing, the cap was depressed after processing, the bi was crushed after processing, no reduction in media/leakage was observed, and there were no punctures on the side of the plastic or media leak. The affected load was initially reported as being reprocessed and not used on a patient. However; upon further follow-up, the customer reported that one bronchoscope was released and used on a patient prior to reprocessing the load. 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 positive velocity? Biological indicators when the load has been released and used on patient(s) prior to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-00015 |
| MDR Report Key | 9741741 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-02-21 |
| 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 | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949453-639 |
| 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 | VELOCITY? 30 BIOLOGICAL INDICATOR |
| Generic Name | INDICATOR, BIOLOGICAL |
| Product Code | FRC |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2019-12-11 |
| Model Number | 43210-30 |
| Catalog Number | 4321030 |
| Lot Number | 2181914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-21 |