MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-09-10 for BD FACS SAMPLE PROCESSOR SP-1 341173 manufactured by Bd Biosciences.
[15447864]
This incident occurred during a routine service call. A field service engineer(fse) was performing a sp-1 probe change. The fse disposing of the contaminated probe. This probe was supposed to be placed in a biohazard container, but the fse tried to place the contaminated probe into the packaging of the new probe before disposing of it. Upon doing this the fse scratched their finger superficially with the old contaminated probe. The fse stated,"why was i so stupid to take the effort to put the tubing over the probe if it was for disposal. A needle is a needle, i should have thrown it away. " this event happened in a hiv-specialized institute.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916837-2004-00001 |
| MDR Report Key | 543302 |
| Report Source | 07 |
| Date Received | 2004-09-10 |
| Date of Report | 2004-09-09 |
| Date of Event | 2004-08-11 |
| Date Mfgr Received | 2004-08-11 |
| Date Added to Maude | 2004-09-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE BROOKS-SMITH |
| Manufacturer Street | 2350 QUME DRIVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089546307 |
| Manufacturer G1 | BD BIOSCIENCES |
| Manufacturer Street | 2350 QUME DRIVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95131 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD FACS SAMPLE PROCESSOR SP-1 |
| Generic Name | APPARATUS AUTOMATED BLOOD CELL DILUTING |
| Product Code | GKH |
| Date Received | 2004-09-10 |
| Model Number | SP-1 |
| Catalog Number | 341173 |
| Lot Number | NA |
| 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 | 532677 |
| Manufacturer | BD BIOSCIENCES |
| Manufacturer Address | 2350 QUME DR. SAN JOSE CA 95131 US |
| Baseline Brand Name | BD PACS SAMPLE PROCESSOR SP-1 |
| Baseline Generic Name | SAMPLE PROCESSOR |
| Baseline Model No | SP-1 |
| Baseline Catalog No | 341173 |
| Baseline Device Family | APPARATUS, AUTOMATED BLOOD CELL DILUTING |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-10 |