FDA Adverse Event
Malfunction
Summary report: N
GRIPPER MICRO SAFETY NEEDLE
MDR report key: 3170415
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00246
- 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
ACCORDING TO THE REPORTER, THE DEVICE WAS INSERTED INTO PT PORTAL SYSTEM AND THE NEEDLE TIP WAS CAPTURED IN THE PRODUCT SAFETY DEVICE; HOWEVER, THE NEEDLE TIP EXTENDED PAST THE SAFETY POSITION ONCE CAPTURED. NO ADVERSE EFFECTS TO PT OR USER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230788 | GRIPPER MICRO SAFETY NEEDLE | FPA - SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | 21-3271 | 32X754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |