EASYTOUCH
Report
- Report Number
- 3005798905-2023-03111
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- April 6, 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 556611P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
REFERENCE (B)(4) 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 556611P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
MCKESSON INVENTORY MANAGER REPORTS THAT ITEM RETAIL LEVEL PACKAGING MIX UP. 831061 SHIPPING CASES IS LABELED WITH 831361. LOT HAS NOT YET BEEN IDENTIFIED.
MCKESSON INVENTORY MANAGER REPORTS THAT ITEM RETAIL LEVEL PACKAGING MIX UP. 831061 SHIPPING CASES IS LABELED WITH 831361. LOT HAS NOT YET BEEN IDENTIFIED.
MCKESSON INVENTORY MANAGER REPORTS THAT ITEM RETAIL LEVEL PACKAGING MIX UP. 831061 SHIPPING CASES IS LABELED WITH 831361. LOT HAS NOT YET BEEN IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1404296 | EASYTOUCH | PEN NEEDLE | FMI | MHC MEDICAL PRODUCTS, LLC | 556611P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |