FDA Adverse Event
Other
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 1640187
·
Received March 19, 2010
Report
- Report Number
- 1722139-2010-00024
- Event Type
- Other
- Date Received
- March 19, 2010
- Date of Event
- January 4, 2010
- Report Date
- March 1, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FOLLOW UP REPORT TO ORIGINAL MDR 2031921-2008-0056. THIS REPORT WAS ORIGINALLY FILED UNDER THE ESTABLISHMENT REGISTRATION (B)(4). THIS FACILITY HAS BEEN CLOSED AND THE PRODUCTS ARE MANUFACTURED BY MOOG MEDICAL (B)(4). THE DEVICE WAS EVALUATED AND THE COMPLAINT WAS CONFIRMED TO LEAK. A SUPPLIER CORRECTIVE ACTION WAS ISSUED TO THE MANUFACTURER. THE MANUFACTURER STATED THAT THERE APPEARED TO BE AN INSUFFICIENT AMOUNT OF SOLVENT USED. CORRECTIVE AND PREVENTATIVE ACTIONS WERE IMPLEMENTED TO MITIGATE FUTURE OCCURRENCES.
Description of Event or Problem · 1
EVENT AS REPORTED: LEAKING AT TUBING CONNECTION ON THE DISTAL TO PUMPING SECTION, WHERE THE GOLD SET CONNECTOR CONNECTS TO THE IV ON THE PT. NO PT INJURY OCCURRED AS A RESULT OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FPA | MOOG MEDICAL DEVICES GROUP | 340-4128 | D70913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |