FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2873597
·
Received November 14, 2012
Report
- Report Number
- 1722139-2012-01153
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT RETURNED. COMPLAINT COULD NOT BE CONFIRMED. DHR REVIEW FOUND ZERO DEFECT IN MANUFACTURING.
Description of Event or Problem · 1
CUSTOMER STATED THAT THERE WAS NO AIR IN LINE IN THE ADMINISTRATION SETS AND THE PUMP WAS ALARMING AIR IN LINE. CUSTOMER WOULD HAVE TO TRY A NEW ADMINISTRATION SET AND THE PUMP WOULD WORK. CUSTOMER ALSO STATES THAT NO PT INVOLVED AND NO ADMINISTRATION SET TO SEND IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4111 | CF1118201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |