MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-15 for RAPICIDE PA manufactured by Medivators.
[145163849]
It was reported by the facility a technician experienced exposure symptoms from rapicide pa high level disinfectant (hld). The facility had moved their advantage plus automated endoscope reprocessor (aer) and as a result, the drain tube got dislodged causing rapicide pa to spill on the floor. The technician in the room thought it was water and attempted to clean the spill up using towels. When the technician left the room, they reported tunnel vision, a metallic taste in their mouth, and that they did not feel well. They were sent to the er. The technician returned to work a few hours later and was reported to be doing fine. Medivators field service engineer was called on site to repair the drain tube. It was also determined that the filter housing was overtightened and leaking. The machine was tested, and it ran within specification. Based on the reported findings of where the source of the spill was from, the fluid would not have been hazardous. The drain solution would have been diluted, hld use solution chemistry that is not hazardous to users. The supervisor at the facility did confirm they have spill kits on site to clean up rapicide pa and admitted that the technician should have been using that at the time he attempted to clean up the leak. The facility did not follow the ifu and sds disposal instructions for rapicide pa hld. This complaint will continue to be monitored in the medivators complaint handling system
Patient Sequence No: 1, Text Type: N, H10
[145163850]
It was reported by the facility a technician experienced exposure symptoms from rapicide pa high level disinfectant (hld).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00040 |
| MDR Report Key | 8613369 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-15 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE NQ |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | FEB |
| Date Received | 2019-05-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 146005 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-15 |