FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2860021
·
Received October 31, 2012
Report
- Report Number
- 1722139-2012-01099
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 1, 2012
- Report Date
- October 1, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) UNUSED ADMINISTRATION SETS OF THE LISTED LOT NUMBER ABOVE WAS RETURNED FOR INVESTIGATION. A ONE HUNDRED PERCENT INSPECTION WAS PERFORMED AND IDENTIFIED THAT (B)(4) ADMINISTRATION SETS CLEARLY HAD THE "BLACK SPEC" INSIDE THE FILTER. FILTER WAS MANUFACTURED BY FILTERTEK. THE (B)(4) ADMINISTRATION SETS WERE SENT TO (B)(4) FOR INVESTIGATION. A F/U WILL BE SENT WHEN NEW INFO IS RECEIVED FROM THE MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTS BLACK SPOTS INSIDE THE FILTER. NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4128 | CF1134392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |