FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 2505486
·
Received March 16, 2012
Report
- Report Number
- 2026095-2012-00035
- Event Type
- Malfunction
- Date Received
- March 16, 2012
- Report Date
- January 17, 2012
- Manufacturer
- I-FLOW CORPORATION
- Product Code
- MEB
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: SAMPLE WAS NOT AVAILABLE FOR RETURN. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.
Description of Event or Problem · 1
DRUG/DILUENT: UNK; FILL VOLUME: UNK; FLOW RATE: UNK; PROCEDURE: UNK; CATHPLACE: UNK. IT WAS REPORTED THAT THE BOLUS BUTTON WAS STUCK IN THE DOWN POSTION. DEVICE WAS PREFILLED THROUGH AMERIDOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | ELASTOMERIC PUMP | MEB | I-FLOW CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |