MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-19 for BACT/ALERT FA 259791 manufactured by Biomerieux Inc..
[608342]
The nurse connected the plastic bact/alert fa bottle to the vacutainer for a blood draw. The blood sample was derived from a catheter. The nurse noticed when the needle was placed in the fa bottle, the blood did not flow. The nurse then observed an air bubble in the pt's vein. The catheter was immediately removed and the air dispersed from the vein. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[7868841]
Bottles contain an atmosphere of co2 in oxygen under vacuum. Studies indicate that, over time, the vacuum increases in the bottle for this particular product. Based on the info received, it appears the phlebotomist may have allowed air from another source (empty iv bag, etc) into the venous access catheter. The air bubble associated with the complaint coming from an fa bottle is highly improbable as there is negative pressure (vacuum) inside the bottle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00001 |
| MDR Report Key | 841738 |
| Report Source | 07 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-18 |
| Date of Event | 2007-04-05 |
| Date Mfgr Received | 2007-04-05 |
| Date Added to Maude | 2007-04-30 |
| 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 | JOHN CUSACK, ASSOCIATE STAFF |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202803 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT FA |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2007-04-19 |
| Model Number | NA |
| Catalog Number | 259791 |
| Lot Number | 1015366 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 828966 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-19 |