MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-08-28 for UNOPETTE MICROCOLLECTION SYSTEM 5856 manufactured by Becton Dickinson Cerro Gordo Industry.
[23905]
Student nurse squeezed reservoir too hard splashing blood and fluid in her face and eyes. This is contrary to package label directions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648228-1996-00001 |
| MDR Report Key | 36172 |
| Report Source | 06 |
| Date Received | 1996-08-28 |
| Date of Report | 1996-08-26 |
| Date of Event | 1996-08-01 |
| Date Mfgr Received | 1996-08-01 |
| Date Added to Maude | 1996-09-03 |
| 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 | 0 |
| 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 | UNOPETTE MICROCOLLECTION SYSTEM |
| Generic Name | WBC DETERMINATION FOR MANUAL METHOD |
| Product Code | GGJ |
| Date Received | 1996-08-28 |
| Model Number | NA |
| Catalog Number | 5856 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 37593 |
| Manufacturer | BECTON DICKINSON CERRO GORDO INDUSTRY |
| Manufacturer Address | ROAD 9/6, KM .8 98 SAN LORENZO PR 00754 US |
| Baseline Brand Name | UNOPETTE MICROCOLLECTION SYSTEM |
| Baseline Generic Name | MANUAL WBC DETERMINATION |
| Baseline Model No | NA |
| Baseline Catalog No | 5856 |
| Baseline ID | NA |
| Baseline Device Family | UNOPETTE BRAND TESTS (UNO) |
| Baseline Shelf Life Contained | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-08-28 |