FDA Adverse Event
Malfunction
Summary report: N
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
MDR report key: 9553365
·
Received January 6, 2020
Report
- Report Number
- 3006425876-2020-00057
- Event Type
- Malfunction
- Date Received
- January 6, 2020
- Date of Event
- December 4, 2019
- Report Date
- December 19, 2019
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). UPON INVESTIGATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE MALFUNCTION WAS NON-REPORTABLE; THUS THE INITIAL MDR, SUBMITTED ON 01/06/2020, WAS SENT IN ERROR.
Description of Event or Problem · 0
THE CUSTOMER REPORTS: THE BASE OF THE NEEDLE TIP BROKE DURING A PUNCTURE ON A PATIENT.
Additional Manufacturer Narrative · 1
QN#: (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTS: THE BASE OF THE NEEDLE TIP BROKE DURING A PUNCTURE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13765 | ARROW CVC SET: 2-LUMEN 7 FR X 20 CM | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL INC. | 71F18J1230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |