FDA Adverse Event
Other
Summary report: N
Q-SYTE LUER ACCESS SITE
MDR report key: 1038766
·
Received May 2, 2008
Report
- Report Number
- 9610847-2008-00036
- Event Type
- Other
- Date Received
- May 2, 2008
- Date of Event
- February 4, 2008
- Report Date
- April 9, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TWO REPRESENTATIVE UNITS WERE RECEIVED ON 21 APRIL 2008. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 02 MAY 2008.
Description of Event or Problem · 1
BLOOD LEAKED BY THE CONNECTOR OF THE PERFUSION LINE AFTER CHANGING A BD Q-SYTE WHICH WAS DIFFICULT TO REMOVE. EXTRA HOSPITALIZATION WAS REQUIRED DUE TO THIS EVENT.
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 | 6055078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |