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 2018-06-26 for RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS ML02-0118 manufactured by Medivators.
[112410168]
A facility reported using expired rapicide pa high level disinfectant test strips for checking the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor. Hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected. The physician who contacted medivators wanted to assess the potential infectious risk to patients that had procedures with endoscopes reprocessed while using the expired test strips. He reported the test strips expired september 2017 and were used as late as early (b)(6) 2018. He also reported the technicians failed to write the date the test strip vial was opened (as indicated on the vial label) to ensure use did not exceed the 4-month open bottle shelf life. Rapicide pa test strips instructions for use warns users to not use the test strips after the expiration date (opened or unopened). The facility reported they reviewed all patient cases from procedures during the time period that expired test strips were used and no infections were noted or patient harm reported. The facility also confirmed they were properly changing the hld solution within 21 days and within the specified shelf life per the rapicide pa hld labeling. This complaint will continue being monitored in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[112410169]
A facility reported using expired rapicide pa high level disinfectant test strips for checking the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor. Hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2018-00044 |
| MDR Report Key | 7639885 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-06 |
| Date Added to Maude | 2018-06-26 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS |
| Generic Name | CHEMICAL INDICATOR |
| Product Code | JOJ |
| Date Received | 2018-06-26 |
| Model Number | ML02-0118 |
| Device Expiration Date | 2017-09-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-26 |