FDA Adverse Event
Malfunction
Summary report: N
HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT
MDR report key: 808367
·
Received November 19, 2004
Report
- Report Number
- 1217052-2004-00095
- Event Type
- Malfunction
- Date Received
- November 19, 2004
- Date of Event
- September 1, 2004
- Report Date
- November 19, 2004
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: VISUAL EXAMINATION DETERMINED THAT, THE REPORT OF "NEEDLE STAYED IN PT'S ARM" WAS DUE TO THE NEEDLE BEING OUT OF EPOXY. A COMPLETE EVALUATION CANNOT BE PERFORMED AS NO LOT NUMBER WAS RECORDED BY THE USER FACILITY. THE NEEDLE HAS BEEN FORWARDED TO THE NEEDLE SUPPLIER (TERUMO MEDICAL CORP.) AND UPON THE COMPLETION OF THEIR EVALUATION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
USER ALLEGES THEY HAD ONE EVENT OF THE STAYING IN THE PT'S ARM AFTER INJECTION. NEEDLE WAS PULLED OUT AND NO INJURY TO CLINICIAN OR PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYPODERMIC NEEDLE-PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT | ACCESSORY TO HYPODERMIC NEEDLES | FMI | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |