EASYTOUCH
Report
- Report Number
- 3005798905-2023-03310
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- April 21, 2023
- Report Date
- April 25, 2023
- Manufacturer
- MHC MEDICAL PRODUCTS, LLC
- Product Code
- FMI
- PMA / PMN Number
- K112789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 568717P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
REFERENCE CR-000071-2023 FOR UPDATING THE INSULIN NEEDLE, PEN NEEDLE AND SAFETY PEN NEEDLE PACKAGING TO IMPROVE VISIBILITY OF ITEM NUMBERS AND THE ABILITY TO SCAN UDI INFORMATION DURING MANUFACTURING PROCESS TO PREVENT PACKAGING MIX-UPS.
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 568717P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
END USER REPORTED THAT THE RETAIL LEVEL PACKAGING MIX UP. RETAIL BOX FOR PEN NEEDLE ITEM NUMBER 831061 (31G 5/16" 8MM), LOT 568717P IS PACKAGED WITH 831041 (31G 1/4" 6MM) PEN NEEDLE INSIDE THE BOX. LOT 568717P IS PRINTED ON THE UDI LABEL.
END USER REPORTED THAT THE RETAIL LEVEL PACKAGING MIX UP. RETAIL BOX FOR PEN NEEDLE ITEM NUMBER 831061 (31G 5/16" 8MM), LOT 568717P IS PACKAGED WITH 831041 (31G 1/4" 6MM) PEN NEEDLE INSIDE THE BOX. LOT 568717P IS PRINTED ON THE UDI LABEL.
END USER REPORTED THAT THE RETAIL LEVEL PACKAGING MIX UP. RETAIL BOX FOR PEN NEEDLE ITEM NUMBER 831061 (31G 5/16" 8MM), LOT 568717P IS PACKAGED WITH 831041 (31G 1/4" 6MM) PEN NEEDLE INSIDE THE BOX. LOT 568717P IS PRINTED ON THE UDI LABEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235340 | EASYTOUCH | PEN NEEDLE | FMI | MHC MEDICAL PRODUCTS, LLC | 568717P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |