MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-21 for AIRLIFE? ARTERIAL BLOOD SAMPLER 9025TRU manufactured by Vyaire Medical..
| Report Number | 8030673-2020-00074 |
| MDR Report Key | 9741633 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-01-25 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-10-09 |
| Date Added to Maude | 2020-02-21 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION85 PARQUE UNDUSTRIAL MEXICALI III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? ARTERIAL BLOOD SAMPLER |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-02-13 |
| Model Number | AIRLIFE? ARTERIAL BLOOD SAMPLER |
| Catalog Number | 9025TRU |
| Lot Number | 0004115370 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |