FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
MDR report key: 7456080
·
Received April 24, 2018
Report
- Report Number
- 1024879-2018-00567
- Event Type
- Malfunction
- Date Received
- April 24, 2018
- Date of Event
- November 2, 2016
- Report Date
- April 19, 2018
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679862
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5329532, MEDICAL DEVICE EXPIRATION DATE: 11/30/2016, DEVICE MANUFACTURE DATE: 11/25/2015. MEDICAL DEVICE LOT #: 6210853, MEDICAL DEVICE EXPIRATION DATE: 07/31/2017, DEVICE MANUFACTURE DATE: 07/28/2016. MEDICAL DEVICE LOT #: 6200680, MEDICAL DEVICE EXPIRATION DATE: 07/31/2017, DEVICE MANUFACTURE DATE: 07/18/2016.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AN ISSUE WITH LOW VACUUM
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299728 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 50382903679862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |