MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-01-18 for manufactured by .
[7868677]
The instrument has been investigated. The field service engineer (fse) evaluated the instrument and found a stuck eject pin in the plunger clamp in the reported problem area of the pipette assembly. The instrument was cleaned, inspected, tested, without further problem, and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250051-2007-00012 |
| MDR Report Key | 830718 |
| Report Source | 05,06 |
| Date Received | 2007-01-18 |
| Date Mfgr Received | 2006-12-19 |
| Device Manufacturer Date | 1995-01-01 |
| Date Added to Maude | 2007-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA VELLUCCI, PH.D. |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188532 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | JTQ |
| Date Received | 2007-01-18 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 818065 |
| Baseline Brand Name | ORTHO SUMMIT SAMPLE HANDLER |
| Baseline Generic Name | SAMPLE HANDLER |
| Baseline Model No | 7003009 |
| Baseline Catalog No | 936400 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-18 |