FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
MDR report key: 7490927
·
Received May 7, 2018
Report
- Report Number
- 1917413-2018-02619
- Event Type
- Malfunction
- Date Received
- May 7, 2018
- Date of Event
- January 31, 2014
- Report Date
- April 26, 2018
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 50382903678612
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3241007. MEDICAL DEVICE EXPIRATION DATE: 01/31/2015. DEVICE MANUFACTURE DATE: 08/29/2013. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES HAD ISSUES WITH LOW MONOS WITHIN SAMPLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335616 | BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. | 3241001 | 50382903678612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |