FDA Adverse Event
Malfunction
Summary report: N
23 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND LUER
MDR report key: 7059969
·
Received November 27, 2017
Report
- Report Number
- 1024879-2017-00514
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- August 25, 2016
- Report Date
- October 24, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903673421
- PMA / PMN Number
- K030573
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A DHR REVIEW IS NOT REQUIRED. REFER TO CAPA (B)(4). 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
IT WAS REPORTED THAT 2 BUTTERFLIES LEAKED BLOOD AT THE TOP (TUBING) END OF THE WHITE PART OF THE NEEDLE FROM A 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER FROM LOT# 6132861. NO SERIOUS INJURY, BLOOD OR MUCOUS EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838789 | 23 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND LUER | BLOOD COLLECTION SET | JKA | BECTON, DICKINSON & CO., (BD) | 6132861 | 00382903673421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |