FDA Adverse Event
Malfunction
Summary report: N
21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
MDR report key: 7064088
·
Received November 28, 2017
Report
- Report Number
- 1024879-2017-00585
- Event Type
- Malfunction
- Date Received
- November 28, 2017
- Date of Event
- September 9, 2016
- Report Date
- October 26, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686501
- PMA / PMN Number
- K982541
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6091734. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER, AFTER BLOOD COLLECTION THE SAFETY NEEDLE SHIELD DOESN'T LOCK, IT CAME OFF OF IT¿S JOINTS. NO INJURY, NO MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 842363 | 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER | BLOOD COLLECTION NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 6091734 | 50382903686501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |