FDA Adverse Event
Injury
Summary report: N
JELCO SAF-T WING BLOOD COLLECTION SET
MDR report key: 2122976
·
Received June 9, 2011
Report
- Report Number
- 2183502-2011-00471
- Event Type
- Injury
- Date Received
- June 9, 2011
- Report Date
- June 7, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JKA
- PMA / PMN Number
- K923090
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED A NURSE RECEIVED A NEEDLE STICK. THE INCIDENT TOOK PLACE AT THE CONCLUSION OF A BLOOD DRAW USING A SYSTEM WITH A SAFETY BUTTERFLY NEEDLE. THE NURSE WAS ATTEMPTING TO ENGAGE THE SAFETY DEVICE. SHE BELIEVED THAT THE DEVICE WAS SAFE; HOWEVER, SHE WAS STUCK BY THE EXPOSED NEEDLE TIP. THE NURSE IS REPORTEDLY RECEIVING MEDICAL TREATMENT CONSISTENT WITH BLOOD EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JELCO SAF-T WING BLOOD COLLECTION SET | JKA - BLOOD SPECIMEN COLLECTION DEVICE | JKA | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |