FDA Adverse Event
Malfunction
Summary report: N
DIRECT CHECK QUALITY CONTROL
MDR report key: 1706804
·
Received May 24, 2010
Report
- Report Number
- 2250033-2010-00008
- Event Type
- Malfunction
- Date Received
- May 24, 2010
- Date of Event
- May 3, 2010
- Report Date
- May 24, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GGN
- PMA / PMN Number
- K944691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MANUFACTURER METHOD - NO PRODUCT RETURNED FROM USER FACILITY. MANUFACTURER RESULTS - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
CUSTOMER REPORTS BEING CUT BY THE DIRECT CHECK CONTROL AMPULE WHILE CRUSHING IT. CUSTOMER WAS CRUSHING THE VIAL IN THE PLASTIC SLEEVE WHEN THEY NOTICED THAT THE CONTROLS WERE NOT COMING OUT OF THE VIALS. CUSTOMER REMOVED THE CRUSHED VIAL FROM THE SLEEVE TO INSPECT WHEREUPON A SMALL PIECE OF GLASS WENT INTO THEIR FINGER. CUSTOMER RECEIVED A TETANUS SHOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT CHECK QUALITY CONTROL | DIRECT CHECK NORMAL ACT-LR | GGN | INTERNATIONAL TECHNIDYNE CORP. | DCJACT-N | K9DNA029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |