FDA Adverse Event
Malfunction
Summary report: N
ACCUFLO CHEMO 2.0ML/H 100ML
MDR report key: 3913074
·
Received June 9, 2014
Report
- Report Number
- 9610825-2014-00197
- Event Type
- Malfunction
- Date Received
- June 9, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K081905
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334225 | ACCUFLO CHEMO 2.0ML/H 100ML | ELASTOMERIC INFUSION PUMPS | FRN | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |