FDA Adverse Event
Malfunction
Summary report: N
VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
MDR report key: 11820269
·
Received May 13, 2021
Report
- Report Number
- 1125230-2021-00049
- Event Type
- Malfunction
- Date Received
- May 13, 2021
- Report Date
- May 13, 2021
- Manufacturer
- GREINER BIO-ONE NA INC.
- Product Code
- FMI
- PMA / PMN Number
- K033478
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT STATEMENT (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. RECEIVED CUSTOMER PICTURE. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.
Description of Event or Problem · 1
CUSTOMER STATES WHEN CLOSING THE SAFETY, THE NEEDLE BENDS OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719794 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | TUBE HOLDER | FMI | GREINER BIO-ONE NA INC. | 450230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |