FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® EDTA 2K
MDR report key: 7456414
·
Received April 24, 2018
Report
- Report Number
- 1917413-2018-00995
- Event Type
- Malfunction
- Date Received
- April 24, 2018
- Date of Event
- December 7, 2016
- Report Date
- June 15, 2018
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- PMA / PMN Number
- K981013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MEDICAL DEVICE TYPE UPDATED TO JKA. 510(K)# UPDATED TO K981013.
Additional Manufacturer Narrative · 0
CORRECTED "DATE RECEIVED BY MANUFACTURER" 12/07/2016.
Additional Manufacturer Narrative · 1
DATE RETURNED TO MANUFACTURER UNKNOWN, USED AWARENESS DATE INSTEAD PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR (B)(4) WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 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 EDTA 2K HAD ITS CAP INSTALLED SLANTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299742 | BD VACUTAINER® EDTA 2K | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. | 6096747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |