FDA Adverse Event
Malfunction
Summary report: N
AW MEDICAL/ASAWI
MDR report key: 2839970
·
Received November 19, 2012
Report
- Report Number
- MW5027665
- Event Type
- Malfunction
- Date Received
- November 19, 2012
- Manufacturer
- AW MEDICAL/ MEDICAL AND BIOTECH DEPOT, INC
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(B)(4) SAFETY SYRINGE COMES OUT OF BODY/CASE WHEN USER PULLS BACK ON HANDLE TO HIDE NEEDLE INSIDE NEEDLE CASE. DEFECTIVE DESIGN. ALSO, NEEDLE NOT STABLE INSIDE CASE. CAN PUSH FROM BEHIND AND NEEDLE WILL PUSH FORWARD. AFTER "SAFETY" MECHANISM WAS ACTIVATED. UNSAFE NEEDLE, SHOULD NOT BE SOLD IN (B)(6). PURCHASED (B)(6) 2008. DATE DISTRIBUTOR BECAME AWARE OF EVENT: (B)(6) 2009. APPROX AGE OF DEVICE: 2 YEARS. LOCATION WHERE EVENT OCCURRED: HOSPITAL. MANUFACTURED IN (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AW MEDICAL/ASAWI | SAFETY NEEDLE | FMI | AW MEDICAL/ MEDICAL AND BIOTECH DEPOT, INC | SS31002212 AND OTHER SIZES | 20070404 AND OTHER LOTS | |
| 2 | AW MEDICAL/ASAWI | SAFETY NEEDLE | FMI | AW MEDICAL/MEDICAL AND BIOTECH DEPOT, INC | SS51006212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |