MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for AMERICAN PROFICIENCY INSTITUTE manufactured by American Proficiency Institute.
[41057927]
Lab technician had mucous membrane exposure from a proficiency specimen. The sample was from american proficiency institute kit (b)(6) for stool occult blood testing. The rubber stopper in the vial shot up on its own before a barrier could be placed over it. The result was specimen from the vial sprayed the left side of the technician's face and made with technicians left eye. Possible contact with left nostril. Technician immediately went to lab's eye wash station and flushed eyes for 5 minutes. Manufacturer sent out a technical bulletin 2 days after receiving shipment. However, it should have said not to even test the product. Enclosed is the emailed notice about possible stopper event. I (exposed technician) has filed an exposure report to employer. I have had no response as to being tested or for the specimen to be tested for pathogen. Still waiting for the protocol to be followed. I report. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061238 |
| MDR Report Key | 5522746 |
| Date Received | 2016-03-22 |
| Date of Event | 2016-03-18 |
| Date Added to Maude | 2016-03-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMERICAN PROFICIENCY INSTITUTE |
| Generic Name | FECAL OCCULT BLOOD SAMPLE |
| Product Code | KHE |
| Date Received | 2016-03-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN PROFICIENCY INSTITUTE |
| Manufacturer Address | 1159 BUSINESS PARK DRIVE TRAVERSE CITY MI 49686 US 49686 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-22 |