FDA Adverse Event
Malfunction
Summary report: N
MIDLINE CATHETERIZATION SET
MDR report key: 3250171
·
Received July 24, 2013
Report
- Report Number
- 3006425876-2013-00128
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- May 6, 2013
- Report Date
- July 1, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K963257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
SEE MDR# 3006425876-2013-00127 FOR THE FIRST EVENT WITH THIS PT. IT IS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT ANTICUBETICAL FOSSA (ACF). LEAKING FROM THE ENTRY POINT DURING ADMINISTRATION WAS NOTED. AS A RESULT, THE CATHETER WAS REMOVED AND ANOTHER MIDLINE WAS INSERTED IN THE RIGHT ACF. THERE WAS NO REPORTED PT INJURY, COMPLICATIONS, OR DEATH. THERE WAS A DELAY IN TREATMENT, BUT IT DID NOT CAUSE HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347069 | MIDLINE CATHETERIZATION SET | MIDLINE CATHETERS | DQY | ARROW INTERNATIONAL INC | ZF1091614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |