FDA Adverse Event
Malfunction
Summary report: N
MICRO-MATE INTERCHANGEABLE GLASS SYRINGES
MDR report key: 3032728
·
Received March 29, 2013
Report
- Report Number
- 1213649-2013-00008
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- April 11, 2012
- Report Date
- April 11, 2012
- Manufacturer
- CADENCE INC.
- Product Code
- FMF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES.
Description of Event or Problem · 1
ON (B)(6) 2011 THE CUSTOMER REPORTED THE GLASS SYRINGE WAS FOUND BROKEN WHEN THE BOX WAS OPENED. THERE WAS NO PT EXPOSURE AND NO INJURY TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130380 | MICRO-MATE INTERCHANGEABLE GLASS SYRINGES | SYRINGE | FMF | CADENCE INC. | 5057 | 77873-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |