MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-05 for UF-1000I UF1000I 05366719 manufactured by Sysmex Corporation.
[51344046]
The user reported that the cap and tubing on the reagent were broken prior to the replacement. The user attached tie straps in an attempt to correct the problem. The splash occurred when replacing the reagent that was attached to the broken tubing. No prior notification of the damage was made to the manufacturer nor was there a request for service. The field service engineer confirmed the damaged reagent tubing and replaced it with a new tubing assembly. The sysmex safety data sheet for reagent ufii pack bac states the reagent is a non-hazardous material. For eye contact, it is recommended to remove contact lenses (if worn), rinse open eye for several minutes under running water. If symptoms persist, consult a doctor. General ppe includes protective gloves and safety glasses. This event will be reported based on the physical reaction of the user to the treatment provided for the reagent splash. There was no report of permanent injury to the user.
Patient Sequence No: 1, Text Type: N, H10
[51344047]
A user was replacing ufii pack bac reagent and splashed reagent in the eyes. Eye protection was not worn as personal protective equipment (ppe) at the time of the event. The user rinsed her eyes out for ten minutes and was sent to employee health. Due to the user's heightened sensitivity to chemicals, employee health treated the user with a "special" eye wash that was not specified in the complaint. The user experienced blurriness as a reaction to the special eye wash and was then treated with steroids. An ophthalmologist determined there was no permanent damage to the user's eyes but requested a few days of rest before returning to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2016-00021 |
| MDR Report Key | 5851811 |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2016-07-14 |
| Device Manufacturer Date | 2010-01-25 |
| Date Added to Maude | 2016-08-05 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER SHEARSTONE |
| Manufacturer Street | 577 APTAKISIC ROAD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439514 |
| Manufacturer G1 | SYSMEX CORPORATION |
| Manufacturer Street | 314-2 KITANO, NOGUCHICHI |
| Manufacturer City | KAKOGAWA, HYOGO 675-0011 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UF-1000I |
| Generic Name | AUTOMATED URINALYSIS ANALYZER |
| Product Code | LKM |
| Date Received | 2016-08-05 |
| Model Number | UF1000I |
| Catalog Number | 05366719 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION |
| Manufacturer Address | 314-2 KITANO, NOGUCHICHI KAKOGAWA, HYOGO 675-0011 JA 675-0011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-05 |