FDA Adverse Event
Malfunction
Summary report: N
ARROW EXT DWELL CATH DEVICE 20GAX8CM
MDR report key: 16277847
·
Received February 1, 2023
Report
- Report Number
- 9680794-2023-00032
- Event Type
- Malfunction
- Date Received
- February 1, 2023
- Date of Event
- November 1, 2022
- Report Date
- January 4, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- FOZ
- PMA / PMN Number
- K151513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
QN#: (B)(4).
Additional Manufacturer Narrative · 0
QN# (B)(4). UPON INVESTIGATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE MALFUNCTION WAS NOT REPORTABLE; THUS THE INITIAL MDR, SUBMITTED ON 02/01/2023, SHOULD BE RETRACTED.
Description of Event or Problem · 0
CUSTOMER REPORTED "CATHETER KINKED/LEAKING." NO PATIENT HARM WAS REPORTED. THE CATHETER WAS REMOVED. THE PATIENTS CONDITION WAS NOT AVAILABLE, AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1375761 | ARROW EXT DWELL CATH DEVICE 20GAX8CM | CATHETER INTRAVASCULAR THERAPE | FOZ | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | NOT REPORTED| NOT REPORTED |