FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SODIUM FLUORIDE BLOOD COLLECTION TUBES
MDR report key: 7493043
·
Received May 7, 2018
Report
- Report Number
- 1917413-2018-01260
- Event Type
- Malfunction
- Date Received
- May 7, 2018
- Date of Event
- August 15, 2017
- Report Date
- May 10, 2018
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 50382903679251
- PMA / PMN Number
- K945952
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDITIONAL PMA# K901449. MEDICAL DEVICE BRAND NAME:BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES. (B)(6). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 123882 WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.
Additional Manufacturer Narrative · 1
CATALOG NUMBER UPDATED TO 367925.
Description of Event or Problem · 1
IT WAS DESCRIBED THAT BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES HAD ISSUES WITH HEMOLYSIS IN TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335282 | BD VACUTAINER® SODIUM FLUORIDE BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. | 7016716 | 50382903679251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |