FDA Adverse Event
Death
Summary report: N
MULTI-LUMEN CVC KIT: 3-L 7 FR
MDR report key: 743803
·
Received August 1, 2006
Report
- Report Number
- 1036844-2006-00055
- Event Type
- Death
- Date Received
- August 1, 2006
- Report Date
- July 31, 2006
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FPB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS BEING PROVIDED FOR EVALUATION. NO LOT NUMBER IS AVAILABLE SO DHR CANNOT BE REVIEWED. FOLLOW-UP REPORT WILL BE FILED IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY FDA (CHIEF INFORMATION & ANALYSIS BRANCH, DIVISION OF SURVEILLANCE SYSTEMS, OFFICE OF SURVEILLANCE & BIOMETRICS) FROM AN ANONYMOUS USER FACILITY THAT DURING INITIAL LINE INSERTION, GUIDEWIRE SEPARATED FROM INNER CORE WIRE WHILE ATTEMPTING TO PULL WIRE OUT AFTER LINE WAS INSERTED. PATIENT EXPIRED, BUT NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN CVC KIT: 3-L 7 FR | ARROWG+ARD CATHETER PRODUCTS | FPB | ARROW INTL., INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |