FDA Adverse Event
Malfunction
Summary report: N
MW5060579
MDR report key: 5466507
·
Received February 24, 2016
Report
- Report Number
- MW5060579
- Event Type
- Malfunction
- Date Received
- February 24, 2016
- Date of Event
- January 18, 2016
- Report Date
- February 24, 2016
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
A 20G INSYTE AUTOGUARD LOT #5191833- THE NEEDLE DID NOT AUTO RETRACT AFTER BUTTON WAS PRESSED. BUTTON REMAINED DEPRESSED, BUT NEEDLE REMAINED OUT. PT WAS NOT HARMED. THE NEEDLE WAS REMOVED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |