MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-05-28 for MP READACRIT DUAL FUNCTION CENTRIFUGE 420593 manufactured by Becton Dickinson.
[21584764]
While using the device, broken glass from some tubes were spun out of a small opening in the centrifuge lid. Some of the debris hit an operator in the facial area. The operator has incurred some unspecified medical expenses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1999-00003 |
| MDR Report Key | 225472 |
| Report Source | 05 |
| Date Received | 1999-05-28 |
| Date of Report | 1999-04-29 |
| Date of Event | 1999-03-25 |
| Date Mfgr Received | 1999-04-29 |
| Device Manufacturer Date | 1981-01-01 |
| Date Added to Maude | 1999-06-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MP READACRIT DUAL FUNCTION CENTRIFUGE |
| Generic Name | CENTRIFUGE, HEMATOCRIT |
| Product Code | GKG |
| Date Received | 1999-05-28 |
| Model Number | NA |
| Catalog Number | 420593 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 218655 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Baseline Brand Name | MP READACRIT DUAL FUNCTION CENTRIFUGE |
| Baseline Generic Name | CENTRIFUGE, HEMATOCRIT |
| Baseline Model No | NA |
| Baseline Catalog No | 420593 |
| Baseline ID | SERIAL # 125154 |
| Baseline Device Family | CENTRIFUGE, EQUIPMENT & SUPPLIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| 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. Required No Informationntervention | 1999-05-28 |