FDA Adverse Event
Malfunction
Summary report: N
BECTON DICKINSON
MDR report key: 2231603
·
Received August 30, 2011
Report
- Report Number
- 2231603
- Event Type
- Malfunction
- Date Received
- August 30, 2011
- Date of Event
- August 26, 2011
- Report Date
- August 30, 2011
- Manufacturer
- BECTON DICKINSON
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN, US
Narratives
Description of Event or Problem · 1
THE PHLEBOTOMIST WAS DRAWING THE PATIENT'S BLOOD. WHEN THIS INDIVIDUAL ATTEMPTED TO PLACE THE BLOOD SPECIMEN TUBE ON THE BACK END OF THE NEEDLE, THE BACK NEEDLE SEPARATED FROM THE HUB. THIS CAUSED THE BLOOD TO SPILL OUT ONTO THE BED AND LINENS.PHLEBOTOMIST WAS NOT EXPOSED DIRECTLY TO THE PATIENT'S BLOOD BECAUSE THIS INDIVIDUAL WAS WEARING GLOVES. THE NEEDLE BROKE OFF AT THE POINT WHERE IT CONNECTS TO THE HOLDER FOR THE SAMPLE TUBES. ANOTHER DEVICE OF THE SAME PRODUCT WAS USED TO OBTAIN THE BLOOD SAMPLE. WE DO NOT KNOW THE LOT NUMBER OF THE SECOND DEVICE. THE SECOND BLOOD DRAW WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BECTON DICKINSON | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET | JKA | BECTON DICKINSON | 367342 | 1145738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES |