FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 4-LUMEN 8.5FR X 20CM
MDR report key: 3021024
·
Received March 20, 2013
Report
- Report Number
- 3006425876-2013-00034
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 19, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT JUGULAR VEIN IN THE INTENSIVE CARE UNIT. DURING INSERTION, THE SPRING WIRE GUIDE UNRAVELED AT THE PROXIMAL END. AS A RESULT, ANOTHER KIT WAS USED SUCCESSFULLY FOR THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115852 | CVC SET: 4-LUMEN 8.5FR X 20CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | ZF2123465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |