MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for SYRINGE 150 UL manufactured by Roche Diagnostics.
[134755015]
The investigation is ongoing. The follow up/corrective actions are to be determined. The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation. This device is labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[134755016]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90078 |
| MDR Report Key | 8286387 |
| Date Received | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STRASSE 1 |
| Manufacturer City | MELSUNGEN, D-3421 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-3421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 150 UL |
| Generic Name | MICRO PIPETTE |
| Product Code | JRC |
| Date Received | 2019-01-29 |
| Model Number | SYRINGE 150 UL |
| Lot Number | 10013153 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |