FDA Adverse Event
Malfunction
Summary report: N
XCELA
MDR report key: 4210124
·
Received October 1, 2014
Report
- Report Number
- 2032582-2014-00007
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- May 19, 2013
- Report Date
- September 2, 2014
- Manufacturer
- PFM MEDICAL, INC
- Product Code
- LJT
- PMA / PMN Number
- K073210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
XCELA POWER INJECTABLE PORT WAS EXPLANTED ON (B)(6) 2014. PRE AND POST IMAGES WERE OBTAINED. PLASTIC HUB WHICH CONNECTS THE PORT TO THE CATHETER WAS NOTED TO BE RETAINED IN THE PATIENT AND REMOVED ON (B)(6) 2014. CONNECTOR IS RADIOTRANSPARENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612061 | XCELA | CATHETER, INTRAVASCULAR, THERAPEUTIC | LJT | PFM MEDICAL, INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |