FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2053353
·
Received March 15, 2011
Report
- Report Number
- 1722139-2011-00033
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 9, 2011
- Report Date
- March 14, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFO PROVIDED IN THE COMPLAINT IS UNCLEAR. CUSTOMER WAS E-MAILED TO ASK FOR CLARIFICATION AND FOR F/U ON RETURNED SAMPLES. A F/U WILL BE SUBMITTED WHEN A RESPONSE FROM THE CUSTOMER IS RECEIVED AND/OR PRODUCT IS RECEIVED AND EVALUATED.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINS THAT THE SYSTEM FILLS WITH AIR AGAIN AT THE BACILLUS FILTER AFTER VENTILATION OF THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4164 | CF1020405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |