EASYTOUCH
Report
- Report Number
- 3005798905-2023-03144
- Event Type
- Injury
- Date Received
- October 27, 2023
- Date of Event
- October 25, 2023
- Report Date
- October 26, 2023
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMI
- PMA / PMN Number
- K112789
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
RESERVED LOT 583317P WAS INVESTIGATED BY THE CMO, NO ABNORMALITIES WERE FOUND DURING THE NEEDLE BONDING FORCE INSPECTION AND INSPECTION OF THE PINCETTE. PHYSICAL PRODUCT RETURNED TO MANUFACTURER FOR TESTING ON 12-1-2023. PRODUCT TESTING RETURNED ON 1-5-2024. THE RETURNED (B)(4)OF PRODUCT WAS TESTED FOR NEEDLE BONDING FORCE TESTS, NO ABNORMALITIES WERE FOUND DURING TESTING.
RESERVED LOT 583317P WAS INVESTIGATED BY THE CMO, NO ABNORMALITIES WERE FOUND DURING THE NEEDLE BONDING FORCE INSPECTION AND INSPECTION OF THE PINCETTE.
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 583317P. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
USER CALLED TO REPORT SHE EXPERIENCED A PN DEPLUG INTO HER PERSON. USER STATES THAT THIS INCIDENT OCCURED WITH TWO PN FROM LOT 53317P EXP 2027-04-01, DUE TO A BRAIN INJURY USER DOES NOT KNOW THE EXACT DATE THEY OCCURED BUT THAT ONE INCIDENT OCCURED LAST WEEK AND THE OTHER TWO WEEKS AGO. USER LIVES IN AN ASSISTED LIVING FACILITY AND DID NOT SEEK MEDICAL ATTENTION DUE TO HER NURSE BEING ABLE TO REMOVE THE DEPLUGGED NEEDLE FROM HER STOMACH WITH TWEEZERS. SHE STATES FOR BOTH INSTANCES USER NOTICED AFTER INJECTING WITH HER BASAGLAR KWIKPEN SHE FELT A BUBBLING SENSATION IN HER ABDOMEN AND ONCE REMOVING THE PN SHE NOTICED THE ENTIRE NEEDLE HAD DETACHED FROM THE BASE.
USER CALLED TO REPORT SHE EXPERIENCED A PN DEPLUG INTO HER PERSON. USER STATES THAT THIS INCIDENT OCCURED WITH TWO PN FROM LOT 53317P EXP 2027-04-01, DUE TO A BRAIN INJURY USER DOES NOT KNOW THE EXACT DATE THEY OCCURED BUT THAT ONE INCIDENT OCCURED LAST WEEK AND THE OTHER TWO WEEKS AGO. USER LIVES IN AN ASSISTED LIVING FACILITY AND DID NOT SEEK MEDICAL ATTENTION DUE TO HER NURSE BEING ABLE TO REMOVE THE DEPLUGGED NEEDLE FROM HER STOMACH WITH TWEEZERS. SHE STATES FOR BOTH INSTANCES USER NOTICED AFTER INJECTING WITH HER BASAGLAR KWIKPEN SHE FELT A BUBBLING SENSATION IN HER ABDOMIN AND ONCE REMOVING THE PN SHE NOTICED THE ENTIRE NEEDLE HAD DETACHED FROM THE BASE.
USER CALLED TO REPORT SHE EXPERIENCED A PN DEPLUG INTO HER PERSON. USER STATES THAT THIS INCIDENT OCCURED WITH TWO PN FROM LOT 53317P EXP 2027-04-01, DUE TO A BRAIN INJURY USER DOES NOT KNOW THE EXACT DATE THEY OCCURED BUT THAT ONE INCIDENT OCCURED LAST WEEK AND THE OTHER TWO WEEKS AGO. USER LIVES IN AN ASSISTED LIVING FACILITY AND DID NOT SEEK MEDICAL ATTENTION DUE TO HER NURSE BEING ABLE TO REMOVE THE DEPLUGGED NEEDLE FROM HER STOMACH WITH TWEEZERS. SHE STATES FOR BOTH INSTANCES USER NOTICED AFTER INJECTING WITH HER BASAGLAR KWIKPEN SHE FELT A BUBBLING SENSATION IN HER ABDOMEN AND ONCE REMOVING THE PN SHE NOTICED THE ENTIRE NEEDLE HAD DETACHED FROM THE BASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1926484 | EASYTOUCH | PEN NEEDLE | FMI | FEEL TECH BIO CO., LTD. | 583317P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |