MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-20 for LABCRAFT I.B. SERUM FILTER manufactured by Porex Medical.
[9045]
Filter inserted into spun tube of blood. Serum should be pourable from inside filter only but, in bad lots, the serum also drips down the outside of the filter onto gloves, tables, hands, etc; exposing lab employees to blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002897 |
| MDR Report Key | 14786 |
| Date Received | 1994-07-20 |
| Date of Report | 1994-07-06 |
| Date of Event | 1994-05-01 |
| Date Added to Maude | 1994-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABCRAFT I.B. SERUM FILTER |
| Product Code | JRL |
| Date Received | 1994-07-20 |
| Lot Number | 113054 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14780 |
| Manufacturer | POREX MEDICAL |
| Manufacturer Address | FAIRBURN GA 30213 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-20 |