FDA Adverse Event
Malfunction
Summary report: N
GRIPPER PLUS NEEDLE
MDR report key: 2881201
·
Received November 16, 2012
Report
- Report Number
- 2183502-2012-00559
- Event Type
- Malfunction
- Date Received
- November 16, 2012
- Date of Event
- October 16, 2012
- Report Date
- November 15, 2012
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- FPA
- PMA / PMN Number
- K072657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: TWO UNUSED SAMPLES WERE RECEIVED FOR EVAL. VISUAL INSPECTION OF THE RETURNED SAMPLES FOUND NO DEFECTS OR ABNORMALITIES. THE PHYSICAL DIMENSIONS OF THE SAMPLES WERE FOUND TO MEET SPECS AND WERE THE CORRECT SIZE. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THE NEEDLE BROKE DURING INSERTION INTO THE PORT AND WAS LEFT INSIDE THE PORT. IT IS UNK HOW THE NEEDLE FRAGMENT WAS REMOVED. NO PT INJURY OR ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRIPPER PLUS NEEDLE | FPA - SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | NA | 31X716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PORT-A-CATH |