FDA Adverse Event
Injury
Summary report: N
BD HUB CUTTER
MDR report key: 3233803
·
Received July 16, 2013
Report
- Report Number
- 2243072-2013-00085
- Event Type
- Injury
- Date Received
- July 16, 2013
- Report Date
- July 16, 2013
- Manufacturer
- BD
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RECEIVED FOR EVAL. HOWEVER, PHOTOS WERE RECEIVED AND ARE PENDING EVAL.
Description of Event or Problem · 1
THE REPORTER STATED THAT A NEEDLE CAME OUT FROM THE HUB CUTTER WALL CONTAINER. THE STAFF EXPERIENCED A NEEDLE STICK INJURY. ADD'L INFO RECEIVED ON (B)(6) 2013, THE REPORTER STATED THAT THE HEALTH CARE WORKER RECEIVED BLOOD WORK AND PROPHYLACTIC MEDICATION AS THE HUB CUTTER WAS CONTAMINATED. THE HEALTH CARE WORKER WILL BE UNDER SURVEILLANCE AND THE NEXT F/U IS SCHEDULED IN THREE MONTHS. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329503 | BD HUB CUTTER | SAFETY BOX-DISPOSAL / HYPODERMIC NEEDLE | FOZ | BD | A12051101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |