FDA Adverse Event
Injury
Summary report: N
IMPRESS DIAGNOSITC PERIPHERAL CATHETER
MDR report key: 4774416
·
Received May 13, 2015
Report
- Report Number
- 1628221-2015-00005
- Event Type
- Injury
- Date Received
- May 13, 2015
- Date of Event
- April 21, 2015
- Report Date
- April 21, 2015
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K053171
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT INFO: LOT NO: E758835, EXP DATE: 02/28/2018. ADD'L LOT INFO: DEVICE MANUFACTURE DATE: 03/2015. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A F/U REPORT WILL BE SENT WHEN THE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE USER REPORTED THAT THE TIP OF THE CATHETER SEPARATED FROM THE SHAFT. THE USER HAS NOT PROVIDED CLINICAL INFO FOR THIS EVENT. TWO LOT NUMBERS WERE PROVIDED FOR THIS COMPLAINT. NO INFO WAS PROVIDED INDICATING WHICH LOT IS RELATED TO THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313408 | IMPRESS DIAGNOSITC PERIPHERAL CATHETER | DQO | MERIT MEDICAL SYSTEMS, INC. | E680436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AMPLATZ WIRE |