FDA Adverse Event
Malfunction
Summary report: N
RA CATH SET: 20 GA X 1-1/2
MDR report key: 4110434
·
Received September 16, 2014
Report
- Report Number
- 9680794-2014-00153
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 25, 2014
- Report Date
- September 8, 2014
- Manufacturer
- ARROW INTERNACIONAL INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE PHYSICIAN WAS INSERTING THE ARTERIAL LINE. THE FLASH WAS SEEN AND THEN BLOOD STARTED COMING OUT OF A HOLE IN THE CATHETER. THE PATIENT HAD A WRIST HEMATOMA AFTER SUCCESSFUL INSERTION OF THE CATHETER WHICH THEN HAD TO BE REMOVED. AS A RESULT, ANOTHER ARTERIAL CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE STAFF ENDED UP WITH BLOOD ON THEM FROM THE BLOOD SEEPING OUT OF THE HOLE IN THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572693 | RA CATH SET: 20 GA X 1-1/2 | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTERNACIONAL INC. | 14F14C0169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |