FDA Adverse Event
Malfunction
Summary report: N
GRIPPER MICRO SAFETY NEEDLE
MDR report key: 3043060
·
Received March 15, 2013
Report
- Report Number
- 2183502-2013-00106
- Event Type
- Malfunction
- Date Received
- March 15, 2013
- Date of Event
- February 15, 2013
- Report Date
- March 14, 2013
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- FPA
- PMA / PMN Number
- K072059
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: ONE USED SAMPLE WAS RECEIVED FOR EVAL. VISUAL INSPECTION OF THE RETURNED SAMPLE OBSERVED A SCORE LINE ON THE CAPTURE SHELF, WHICH IS CONSISTENT WITH THE ARM HAVING BEEN PULLED WITH EXCESSIVE FORCE BEYOND THE CAPTURE SHELF AND SHEARING THE TABS. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT AFTER THE DEVICE'S INSERTER WAS REMOVED FROM USE, THE NEEDLE WOULD NOT FULLY ENGAGE INTO THE SAFETY MECHANISM. NO NEEDLESTICK OR INJURY TO USER TOOK PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110440 | GRIPPER MICRO SAFETY NEEDLE | FPA | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | 21-3256 | 32X883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PORT-A-CATH |