FDA Adverse Event
Other
Summary report: N
BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 1031759
·
Received April 18, 2008
Report
- Report Number
- 1710034-2008-00050
- Event Type
- Other
- Date Received
- April 18, 2008
- Report Date
- April 8, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED FROM THE CUSTOMER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 04/17/2008.
Description of Event or Problem · 1
EIGHT HRS AFTER INSERTION OF THE CATHETER, INFLAMMATION AND IRRITATION APPEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 7239165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |