FDA Adverse Event
Malfunction
Summary report: N
CLINICATH PERIPHERALLY INSERTED CATHETER
MDR report key: 5161668
·
Received February 6, 2004
Report
- Report Number
- 2183502-2004-00003
- Event Type
- Malfunction
- Date Received
- February 6, 2004
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
- Product Code
- LJS
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. AS PER DIRECTION RECEIVED FROM THE FDA ON 12/09/1999; THE MANUFACTURER COMPLETES IN IT'S ENTIRETY REGARDLESS IF THE USER FACILITY COMPLETES ALL OR ANY, THEREFORE MAY CONTAIN CORRECTED AND/OR ADDITIONAL DATA.
Description of Event or Problem · 1
REFERENCE UF #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINICATH PERIPHERALLY INSERTED CATHETER | PICC LINE | LJS | SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) | 21-2984 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |