FDA Adverse Event
Malfunction
Summary report: N
DIRECT CHECK QUALITY CONTROL
MDR report key: 1624925
·
Received February 19, 2010
Report
- Report Number
- 2250033-2010-00002
- Event Type
- Malfunction
- Date Received
- February 19, 2010
- Date of Event
- January 1, 2010
- Report Date
- February 19, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GGN
- PMA / PMN Number
- K944691
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MANUFACTURER METHOD AND RESULTS - MANUFACTURER UNABLE TO PERFORM EVAL AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM THE USER FACILITY. DEVICE HISTORY RECORD REVIEWED. MANUFACTURER CONCLUSIONS CODE - NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
CUSTOMER REPORTS A NURSE BEING CUT BY THE AMPULE WHILE CRUSHING THE DIRECT CHECK CONTROL VIAL. CUSTOMER DID NOT KNOW IF THE PRODUCT'S PROTECTIVE SLEEVE WAS USED, WHICH IS PROVIDED FOR USE WHEN CONTROL VIALS ARE ACTIVATED. NO REPORT OF SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT CHECK QUALITY CONTROL | DIRECT CHECK CONTROL ACT-LR | GGN | INTERNATIONAL TECHNIDYNE CORP. | DCJLR-A | H9DCA016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |