FDA Adverse Event
Malfunction
Summary report: N
23 G X .75 IN. BD VACUTAINER® BLOOD COLLECTION SET
MDR report key: 7060208
·
Received November 27, 2017
Report
- Report Number
- 1024879-2017-00272
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- March 22, 2016
- Report Date
- October 20, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903673360
- PMA / PMN Number
- K030573
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5222969. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.
Description of Event or Problem · 1
DURING BLOOD SAMPLING, LEAKAGE OCCURRED AT 2 DIFFERENT LOCATIONS ON THE TUBING OF 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE INVOLVED UNIT WAS DISCARDED. NO MUCOUS MEMBRANE EXPOSURE. NO SAMPLE WAS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838949 | 23 G X .75 IN. BD VACUTAINER® BLOOD COLLECTION SET | BLOOD COLLECTION SET. | JKA | BECTON, DICKINSON & CO., (BD) | 5222969 | 00382903673360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |