FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿
MDR report key: 7059004
·
Received November 27, 2017
Report
- Report Number
- 1917413-2017-00220
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- January 5, 2016
- Report Date
- October 28, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 50382903697149
- PMA / PMN Number
- K945952
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS - THREE SAMPLES WERE RECEIVED. ONE TUBE HAD GLASS BREAKAGE AND NO ADDITIVE IN THE TUBE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5089837. CONCLUSION - DURING THE FORMING PROCESS A J CRACK MAY HAVE FORMED. BECAUSE OF THE GLASS BREAK, ADDITIVE LEAKED OUT. THIS CAN BE SEEN BY THE LIQUID DAMAGE THAT IS ON THE LABEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT 13 X 75 MM X 4.5 ML BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿ WAS MISSING ANTICOAGULANT AND HAD BROKEN/CRACKED GLASS UNDER THE LID. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840795 | BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿ | BLOOD COLLECTION TUBE | JKA | BECTON, DICKINSON & CO. | 5089837 | 50382903697149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |