FDA Adverse Event
Malfunction
Summary report: N
NIPRO HYPODERMIC NEEDLE
MDR report key: 1811185
·
Received August 13, 2010
Report
- Report Number
- 1056186-2010-00002
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 22, 2010
- Manufacturer
- NIPRO MEDICAL CORPORATION
- Product Code
- FMI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
VISUAL, DIMENSIONAL AND MECHANICAL TESTING PERFORMED ON SAME LOT OF PRODUCT. ALL RESULTS WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
A NIPRO HYPODERMIC NEEDLE (25G X 1") WAS USED FOR A LIPO B INJECTION INTO THE GLUTEUS. THE PATIENT CALLED THE FACILITY AFTER SHE GOT HOME, STATING THAT SHE WAS FEELING PAIN IN THE INJECTION SITE AND THAT HER HUSBAND FOUND A LITTLE PIECE OF THE NEEDLE TIP STUCK IN HER SKIN. IT WAS REMOVED WITHOUT FURTHER INCIDENT AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NIPRO HYPODERMIC NEEDLE | HYPODERMIC NEEDLE | FMI | NIPRO MEDICAL CORPORATION | AH+2525 | 09L11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |