MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for VACUETTE BLOOD COLLECTION TUBES COAGULATION SODIUM CITRATE / CTAD 454322 manufactured by Greiner Bio-one Na Inc.
| Report Number | 1125230-2020-00001 |
| MDR Report Key | 9802713 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MANFRED ABEL |
| Manufacturer Street | 4238 CAPITAL DRIVE |
| Manufacturer City | MONROE NC 28110 |
| Manufacturer Country | US |
| Manufacturer Postal | 28110 |
| Manufacturer Phone | 7042617823 |
| Manufacturer G1 | GREINER BIO-ONE NA INC |
| Manufacturer Street | 4238 CAPITAL DRIVE |
| Manufacturer City | MONROE NC 28110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28110 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 20-87 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACUETTE BLOOD COLLECTION TUBES COAGULATION SODIUM CITRATE / CTAD |
| Generic Name | TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT |
| Product Code | GIM |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-26 |
| Model Number | 454322 |
| Catalog Number | 454322 |
| Lot Number | B1908355 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREINER BIO-ONE NA INC |
| Manufacturer Address | 4238 CAPITAL DRIVE MONROE NC 28110 US 28110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |