FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 3-L 7 FR X 8
MDR report key: 1022878
·
Received March 28, 2008
Report
- Report Number
- 1036844-2008-00048
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- K993691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED, BY THE CLINICIAN, THAT THE CATHETER CAME OUT OF THE PT. IT WAS NOTED, THE CATHETER WAS SUTURED ON THE PT. THE SALES REP TRIED ON TWO OCCASIONS TO OBTAIN MORE INFORMATION BUT THE CONTACT HAS NO FURTHER DETAILS, AND HAS NOT OFFERED TO OBTAIN INFO. NO FURTHER DETAILS ARE AVAILABLE. ON 03/20/08 UPDATE: THE SALES REP TRIED TO GATHER MORE INFO. SHE WAS TOLD BY THE NURSE THAT "SHE DOESN'T HAVE TIME TO RESEARCH ANY INFO ON THIS INCIDENT. THEY ARE GOING TO BE ON STRIKE IN 10 DAYS AND SHE HAS NO TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 | ARROWGUARD CATHETER PRODUCTS | DQO | ARROW INTL., INC. | RL8016393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |