FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2190574
·
Received July 27, 2011
Report
- Report Number
- 1722139-2011-00148
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- Removal / Correction Number
- Z-1444-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT 340-4128, LOT CF 1018802 IS CURRENTLY UNDER RECALL #Z-1444-2011.
Description of Event or Problem · 1
INFO RECEIVED ALLEGES MICROBUBBLES ARE FORMING IN THE SOFT TUBING SEGMENT CAUSING NUISANCE AIR IN LINE ALARM WHICH CANNOT BE REMEDIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4128 | CF 1018802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CURLIN INFUSION PUMP |