FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2215884
·
Received August 9, 2011
Report
- Report Number
- 1722139-2011-00193
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 24, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Removal / Correction Number
- Z-1440-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NUMBER 340-4114, LOT NUMBER D100319 IS CURRENTLY UNDER RECALL Z-1440-2011.
Description of Event or Problem · 1
CAREGIVER ALLEGED AIR-IN-LINE ALARM OCCURS AFTER ABOUT 30 MINUTES OF INFUSION. TINY BUBBLES FORM IN THE SOFT TUBING SEGMENT. THE IVS ARE USED FOR HYDRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4114 | D100319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |