FDA Adverse Event
Malfunction
Summary report: N
BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES
MDR report key: 7494944
·
Received May 8, 2018
Report
- Report Number
- 9617032-2018-02328
- Event Type
- Malfunction
- Date Received
- May 8, 2018
- Date of Event
- September 5, 2017
- Report Date
- April 27, 2018
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903660655
- PMA / PMN Number
- K953994
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 132623 WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. 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 SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES HAD ISSUES WITH UNDERFILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336030 | BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 6312552 | 50382903660655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |