FDA Adverse Event
Other
Summary report: N
BD VACUTAINER PLUS PLASTIC CITRATE TUB
MDR report key: 2831318
·
Received November 1, 2012
Report
- Report Number
- 1917413-2012-00004
- Event Type
- Other
- Date Received
- November 1, 2012
- Date of Event
- September 26, 2012
- Report Date
- October 31, 2012
- Manufacturer
- BD
- Product Code
- JKA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENTS OCCURRED BETWEEN (B)(6) 2012. SAMPLE HAVE BEEN REC'D AND IS UNDER INVESTIGATION. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT 70 PTS HAD ELEVATED (ERRONEOUS) COAGULATION RESULTS. TWO PTS HAD DELAYED SURGERY AND ONE PT HAD HOSPITAL STAY WHICH WAS LENGTHENED BY 2 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD VACUTAINER PLUS PLASTIC CITRATE TUB | 13X75 MM PLASTIC CITRATE TUBE | JKA | BD | 2180434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |