FDA Adverse Event
Other
Summary report: N
Q-SYTE LUER ACCESS SITE
MDR report key: 1385940
·
Received May 14, 2009
Report
- Report Number
- 9610847-2009-00023
- Event Type
- Other
- Date Received
- May 14, 2009
- Date of Event
- April 12, 2009
- Report Date
- April 16, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON 06 MAY 2009 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
BD Q-SYTE WAS ATTACHED TO STOPCOCK AND LEAKED A CHEMOTHERAPY DRUG. THE NURSE WASN'T SURE IF IT LEAKED THROUGH THE SPLIT SEPTUM OR THE LUER CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Q-SYTE LUER ACCESS SITE | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |