FDA Adverse Event
Malfunction
Summary report: N
GRIPPER PLUS NEEDLE
MDR report key: 3842568
·
Received February 24, 2014
Report
- Report Number
- 2183502-2014-00049
- Event Type
- Malfunction
- Date Received
- February 24, 2014
- Date of Event
- January 24, 2014
- Report Date
- February 21, 2014
- Manufacturer
- SMITHS MEDICAL
- Product Code
- FPA
- PMA / PMN Number
- K021999
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
USER FACILITY REPORTED UPON REMOVAL OF DEVICE FROM PT, NEEDLE BECAME DISENGAGED FROM SAFETY MECHANISM. NO ADVERSE EFFECTS TO PT OR USER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112714 | GRIPPER PLUS NEEDLE | FPA - SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL | 21-2768 | 33X459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PORT-A-CATH |