FDA Adverse Event
Malfunction
Summary report: N
VACUETTE® TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75
MDR report key: 23270707
·
Received October 10, 2025
Report
- Report Number
- 1125230-2025-00046
- Event Type
- Malfunction
- Date Received
- October 10, 2025
- Report Date
- October 9, 2025
- Manufacturer
- GREINER BIO-ONE NA INC.
- Product Code
- GIM
- PMA / PMN Number
- K971221
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT (B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. THE COMPLAINT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 0
COMPLAINT (B)(4): SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER BUT HAVE NOT YEAR BEEN RECEIVED AT THE TIME OF THIS REPORT. IF AND WHEN CUSTOMER SAMPLES ARE RECEIVED, THEY WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
CUSTOMER REPORTED THE TUBES UNDERFILLED OVER THE LAST COUPLE MONTHS. MULTIPLE USERS. TUBES COLLECTED PER IFU. CUSTOMER PHOTOS PROVIDED. TS PROVIDED CUSTOMER COAGULATION TUBE LITERATURE AND DRAW VOLUME EDUCATION FOR FILL INDICATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2461158 | VACUETTE® TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 | EVACUATED BLOOD COLLECTION TUBE | GIM | GREINER BIO-ONE NA INC. | 454332 | B2502349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |