FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3072400
·
Received April 11, 2013
Report
- Report Number
- 3072400
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 11, 2013
- Manufacturer
- BECTON, DICKINSON & COMPANY
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
Narratives
Description of Event or Problem · 1
THIS MORNING THE LAB SUPERVISOR IDENTIFIED AN ISSUE WITH RECENT SHIPMENT OF BD ITEM REF 367344 GREEN BUTTERFLY NEEDLES, LOT#3047784, EXPIRATION DATE OF 02/2015. THE LAB SUPERVISOR NOTIFIED THE BD REP OF THE ISSUE. THERE IS A DEFECT IN SOME OF THESE THAT CAN BE VISUALLY SEEN AS HOLES IN THE TUBING. THIS APPEARS TO BE A RECENT LOT SHIPMENT. WE HAVE PULLED ALL OF THIS ITEM FROM LAB AND NETWORK REFERENCE LAB DRAW SITES AND HAVE THEM IN THE LAB.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155727 | * | SET, BLOOD COLLECTION | JKA | BECTON, DICKINSON & COMPANY | * | 3047784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | OTHER |