FDA Adverse Event
Malfunction
Summary report: N
ACCESS TRAY
MDR report key: 1230360
·
Received November 7, 2008
Report
- Report Number
- 1036844-2008-00237
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 10, 2008
- Report Date
- November 7, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FOZ
- PMA / PMN Number
- K930129
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 THAT THE SHEATH HUB DISCONNECTED FROM THE SHEATH BODY. INFO RECEIVED 11/05/08 STATES: "THE ESTIMATED TIME, THE PRODUCT WAS IN THE PT WAS NO MORE THAN 10 MINUTES. THERE WAS NOTHING BEING ADMINISTERED AT THE TIME. THE PATIENT'S CONDITION AS A RESULT IS UNK. THE CLINICIAN WAS ABLE TO TOTALLY REMOVE THE FRAGMENTS AS SEVERAL MM WAS SHOWING ABOVE THE SKIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS TRAY | PERIPHERALLY INSERTED CENTRAL CATHETERS | FOZ | ARROW INTL., INC. | RF8020904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |