FDA Adverse Event
Malfunction
Summary report: N
SAF-T WING BLOOD COLLECTION & INFUSION SET
MDR report key: 3963946
·
Received May 22, 2014
Report
- Report Number
- 2183502-2014-00328
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- May 21, 2014
- Manufacturer
- SMITHS MEDICAL INC.
- Product Code
- FPA
- PMA / PMN Number
- K895705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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. MANUFACTURER'S REFERENCE: (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT FOLLOWING USE OF THE DEVICE, THE NEEDLE COULD NOT BE FULLY RETRACTED INTO THE SAFETY MECHANISM, LEAVING THE NEEDLE EXPOSED. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304244 | SAF-T WING BLOOD COLLECTION & INFUSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |