FDA Adverse Event
Malfunction
Summary report: N
VACUETTE BLOOD COLLECTION TUBES EDTA
MDR report key: 12863584
·
Received November 23, 2021
Report
- Report Number
- 1125230-2021-00086
- Event Type
- Malfunction
- Date Received
- November 23, 2021
- Report Date
- November 23, 2021
- Manufacturer
- GREINER BIO-ONE NA INC.
- Product Code
- JKA
- PMA / PMN Number
- K042927
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT STATEMENT (B)(4) : NO DATE OF THE EVENT COULD BE OBTAINED FROM THE CUSTOMERS. NO SAMPLES WERE RECEIVED FOR EVALUATION. NO CUSTOMER PICTURES WERE RECEIVED. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. NO FURTHER INFORMATION OR CLARIFICATION WAS RECEIVED FROM THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 0
CUSTOMER STATES: LAVENDER TUBES-BUBBLES CAUSING ASPIRATION ERRORS ON DXH 600S. THE REF # (B)(4) WERE MENTIONED FOR THE LAVENDER TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1764253 | VACUETTE BLOOD COLLECTION TUBES EDTA | EVACUATED BLOOD COLLECTION TUBES | JKA | GREINER BIO-ONE NA INC. | 454246, 454209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |