FDA Adverse Event
Other
Summary report: N
FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 1356391
·
Received April 2, 2009
Report
- Report Number
- 1710034-2009-00054
- Event Type
- Other
- Date Received
- April 2, 2009
- Date of Event
- February 12, 2009
- Report Date
- March 3, 2009
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON 03/23/2009 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
THE CUSTOMER REPORTED THAT 5 DAYS AFTER INSERTION OF THE CATHETER, OBSERVED SKIN IRRITATION AND HYPEREMIA. THE CATHETER WAS REMOVED ON (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 8092977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 DA | Other | ALCOHOLIC CHLOROHEX |