FDA Adverse Event
Other
Summary report: N
BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 872911
·
Received June 27, 2007
Report
- Report Number
- 1710034-2007-00061
- Event Type
- Other
- Date Received
- June 27, 2007
- Date of Event
- June 8, 2007
- Report Date
- June 18, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ONE USED UNIT WAS REC'D ON 25 JUNE 2007 AND SENT FOR DECONTAMINATION. UPON DECONTAMINATION OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER WAS INSERTED IN 2007. APPROXIMATELY, 3 MONTHS LATER, THE PT HUNG THE TUBE OF THE INFUSION SET STEPPING AND THE CATHETER CUT. THE LINE HAD TO BE SECURED AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | LJS | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other |