FDA Adverse Event
Other
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 1893915
·
Received November 2, 2010
Report
- Report Number
- 1722139-2010-00098
- Event Type
- Other
- Date Received
- November 2, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 2, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER WAS NOT PROVIDED. THIS COMPLAINT WAS NOT CONFIRMED.
Description of Event or Problem · 1
AS REPORTED: PT REPORTED THERE WAS A SLICE IN THE TUBING, IT WAS LEAKING AND THE MEDICATION DID NOT FLOW PROPERLY. NO INJURY OCCURRED AS A RESULT OF THIS COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4114 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |