FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 17220992
·
Received June 28, 2023
Report
- Report Number
- 3005798905-2023-03125
- Event Type
- Malfunction
- Date Received
- June 28, 2023
- Date of Event
- June 27, 2023
- Report Date
- June 28, 2023
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMI
- PMA / PMN Number
- K112789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CMO INSPECTED RETAINED LOT 583314P FOR PEN NEEDLE CAP COMPATIBILITY, NO ABNORMALITIES WERE FOUND DURING TESTING.
Additional Manufacturer Narrative · 0
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 583314P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
Description of Event or Problem · 0
END USER REPORTS THAT EASYTOUCH PN ITEM 831361 LOT 583314P THAT THE NEEDLE HUB IS DIFFICULT TO REMOVE AFTER INJECTION. THE END USER IS USING A HUMALOG KWIKPEN AND THERE IS NO DIFFICULTY WHEN ATTACHING THE PN TO THE KWIKPEN.
Description of Event or Problem · 0
END USER REPORTS THAT EASYTOUCH PN ITEM 831361 LOT 583314P THAT THE NEEDLE HUB IS DIFFICULT TO REMOVE AFTER INJECTION. THE END USER IS USING A HUMALOG KWIKPEN AND THERE IS NO DIFFICULTY WHEN ATTACHING THE PN TO THE KWIKPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168789 | EASYTOUCH | PEN NEEDLE | FMI | FEEL TECH BIO CO., LTD. | 583314P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |