FDA Adverse Event
Injury
Summary report: N
SINGLE TRAY KIT
MDR report key: 1033995
·
Received April 25, 2008
Report
- Report Number
- 2242445-2008-00012
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- February 24, 2008
- Report Date
- April 25, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LJT
- PMA / PMN Number
- K9333350
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CLINICIAN THAT TWO MONTHS AFTER IMPLANTATION (EXACT DATE OF IMPLANT UNKNOWN), THE CATHETER WAS FOUND BROKEN IN THE PATIENT. INFORMATION RECEIVED 3/28/08: "FOR YOUR INFORMATION, THE CATHETER WAS FOUND BROKEN WHEN THE DOCTOR ATTEMPTED TO GIVE MEDICINE. THE CATHETER WAS THEN REMOVED IN THE CATH-LAB, AND THE PORT WAS ALSO REMOVED. THE PATIENT THEN WENT HOME. PLEASE LET ME KNOW IF FURTHER ASSISTANCE IS NEEDED." INVESTIGATION INTO THIS COMPLAINT IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE TRAY KIT | THEREX IMPLANTABLE PORTS | LJT | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |