FDA Adverse Event
Malfunction
Summary report: N
"Y" EXTENSION SET
MDR report key: 1920970
·
Received December 7, 2010
Report
- Report Number
- 9616066-2010-00349
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- May 31, 2010
- Report Date
- June 10, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 12/07/2010. (B)(4). PRESSURE TESTING CONFIRMED THE CUSTOMER'S COMPLAINT AS LEAKAGE WAS OBSERVED FROM A CRACK IN THE FEMALE LUER. IT WAS NOT POSSIBLE TO IDENTIFY THE EXACT ROOT CAUSE OF THE CRACK.
Description of Event or Problem · 1
THE USER REPORTED THAT AFTER THE SET HAD BEEN IN USE ON THE PT FOR 1 DAY, THEY NOTICED A LEAK FROM A CRACK IN THE FEMALE LUER. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | "Y" EXTENSION SET | FPA | CAREFUSION CORPORATION | 30852 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |