FDA Adverse Event
Malfunction
Summary report: N
22 G X 1 IN. BD ECLIPSE¿ NEEDLE
MDR report key: 5442208
·
Received February 17, 2016
Report
- Report Number
- 8041187-2016-00009
- Event Type
- Malfunction
- Date Received
- February 17, 2016
- Date of Event
- January 29, 2016
- Report Date
- February 2, 2016
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- PMA / PMN Number
- K010188
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5141112. THE DEFECT WAS NOT AFFECTED BY PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT. AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OF NOTE, (B)(4) HAS BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SAFETY SHIELD BROKE OFF THE SUSPECT DEVICE WHEN ACTIVATING. A NURSE RECEIVED A NEEDLE STICK INJURY ALTHOUGH HE/SHE DID NOT HAVE ANY BLOOD EXPOSURE AS A RESULT OF THE INCIDENT AND IS REPORTED AS BEING "OKAY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99180 | 22 G X 1 IN. BD ECLIPSE¿ NEEDLE | HYPODERMIC NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 5141112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |