FDA Adverse Event
Other
Summary report: N
INSYTE IV CATHETER
MDR report key: 1062845
·
Received June 18, 2008
Report
- Report Number
- 1710034-2008-00075
- Event Type
- Other
- Date Received
- June 18, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 6, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 18 JUNE 2008.
Description of Event or Problem · 1
THE PATIENT HAD THE IV INSERTED IN 2008, AND A COLONOSCOPY WAS PERFORMED. THE CATHETER WAS REMOVED AND THE PATIENT WAS RELEASED. TWO DAYS LATER THE PATIENT RETURNED COMPLAINING OF PAIN AND SWELLING AT THE IV SITE. A MINOR PROCEDURE WAS COMPLETED AND A SMALL PIECE OF THE CATHETER WAS REMOVED. THE PATIENT WAS THEN DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYTE IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 7179890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |