FDA Adverse Event
Injury
Summary report: N
BD SAFETY-LOK BLOOD COLLECTION SET
MDR report key: 3060293
·
Received April 11, 2013
Report
- Report Number
- 2243072-2013-00024
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 6, 2013
- Report Date
- April 10, 2013
- Manufacturer
- BD
- Product Code
- JKA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.
Description of Event or Problem · 1
ON (B)(6) 2013, THE REPORTER STATED THAT ON (B)(6) 2013, DURING USE OF A BUTTERFLY NEEDLE ON A PATIENT'S HAND, THE NEEDLE SLIPPED OUT AND LIGHTLY SCRATCHED THE RIGHT INDEX FINGER OF THE PERSON THAT WAS OBTAINING THE BLOOD. A SOFT POKE WAS FELT. RECEIVED ADDITIONAL INFORMATION VIA EMAIL FROM THE COUNTRY COORDINATOR ON (B)(6) 2013, THE PERSON WHO EXPERIENCED THE NEEDLE STICK, RECEIVED ANTI-RETROVIRAL TREATMENT FOR HEP C PREVENTION. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154266 | BD SAFETY-LOK BLOOD COLLECTION SET | 23 GX 0.75 IN NEEDLE X 12 IN TUBING | JKA | BD | 2272845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |