FDA Adverse Event
Injury
Summary report: N
26GA X 1/2 INCH NEEDLE
MDR report key: 3952071
·
Received July 17, 2014
Report
- Report Number
- 2243072-2014-00149
- Event Type
- Injury
- Date Received
- July 17, 2014
- Report Date
- July 18, 2014
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT IS UNK AT THIS TIME IF SAMPLES ARE AVAILABLE FOR EVAL. REQUESTS FOR ADD'L INFO REGARDING THE INCIDENTS HAVE BEEN MADE. IF SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE BD NEEDLES WERE USED ON CATARACT OPERATION PTS. TWENTY-FIVE PTS HAD COMPLICATIONS SUCH AS REDNESS ON THE EYES, SEVERE PAIN OR COMPLICATIONS ON THE PUPILLARY MEMBRANE AND AC CELLS. THE PTS WERE TREATED WITH A STEROID. SAMPLES OF THE NEEDLES SENT TO THE LABORATORY FOR CULTURE TESTED POSITIVE FOR STAPHYLOCOCCUS HAEMOLYTICUS BACTERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420308 | 26GA X 1/2 INCH NEEDLE | SMALL BORE NEEDLE | FPA | BECTON DICKINSON | 2355472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |