FDA Adverse Event
Malfunction
Summary report: N
GRIPPER MICRO SAFETY NEEDLE
MDR report key: 3170395
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00245
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 23, 2013
- Report Date
- May 22, 2013
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- FPA
- PMA / PMN Number
- K072059
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN PT USE. ACCORDING TO THE REPORTER THE DEVICE'S INSERTER NEEDLE WAS REMOVED FORM PT AND USER ATTEMPTED TO WITHDRAW THE INSERTER NEEDLE INTO THE SAFETY POSITION. ACCORDING TO THE REPORTER THE NEEDLE COULD NOT BE CAPTURED INTO THE SAFETY POSITION. NO ADVERSE EFFECTS TO PT OR USER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231679 | GRIPPER MICRO SAFETY NEEDLE | FPA - SET, ADMINISTRAITON, INTRAVASCULAR | FPA | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | 21-3271 | 32X754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |