FDA Adverse Event
Malfunction
Summary report: N
CLINICATH PERIPHERALLY INSERTED CATHETER
MDR report key: 2212477
·
Received March 12, 2007
Report
- Report Number
- 2183502-2007-00075
- Event Type
- Malfunction
- Date Received
- March 12, 2007
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- LJS
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: ONE USED 16 GAUGE 65 CENTIMETER DUAL-LUMEN PICC LINE WAS RETURNED FOR EVALUATION. DURING VISUAL EXAMINATION, IT WAS NOTED THE CATHETER WAS DAMAGED APPROXIMATELY 2 1/2-INCHES DISTAL TO THE BIFURCATION THE DAMAGE CONSISTS OF A RUPTURE TO ONE OF THE LUMENS, THE CATHETER MATERIAL APPEARS STRETCHED AS IF THE CATHETER WALL HAS BALLOONED AND RUPTURED. THIS KIND OF DAMAGE IS CONSISTENT WITH OVER-PRESSURIZATION. THE RUPTURED LUMEN IS OCCLUDED WITH A MATERIAL CONSIST WITH DRIED BLOOD DISTAL TO THE RUPTURE AND THE CATHETER IS PATENT PROXIMAL TO THE RUPTURE.
Description of Event or Problem · 1
SURGICAL PROCEDURE, ADDITIONAL.
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 | M49769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |