FDA Adverse Event
Other
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 1714367
·
Received June 2, 2010
Report
- Report Number
- 1722139-2010-00066
- Event Type
- Other
- Date Received
- June 2, 2010
- Date of Event
- April 27, 2010
- Report Date
- April 28, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT INFORMATION WAS AVAILABLE. THE RETURNED PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION. IF THE PRODUCT IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. NO CLINICAL INJURY TO PT.
Description of Event or Problem · 1
AS REPORTED: TWO SLITS FOUND IN THE ADMIN SET UPON START OF INFUSION. STARTED TO LEAK. NO INJURY OCCURRED AS A RESULT OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4168 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |