FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 19974252
·
Received August 13, 2024
Report
- Report Number
- 3005798905-2024-03198
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- August 8, 2024
- Report Date
- August 13, 2024
- Manufacturer
- BERPU MEDICAL TECHNOLOGY 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
RETAINED LOT SAMPLES FOR SYRINGE LOT 61165 WERE TESTED FOR NEEDLE SHARPNESS AND LUBRICATION QUALITY. NO ABNORMALITIES WERE FOUND DURING TESTING.
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 61165 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 61165. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Description of Event or Problem · 0
END USER REPORTS THAT WHILE USING PEN NEEDLES ITEM NUMBER 831361 LOT 61165, MULTIPLE CANNULAS ARE DULL AND WILL NOT PUNCTURE SKIN.
Description of Event or Problem · 0
END USER REPORTS THAT WHILE USING PEN NEEDLES ITEM NUMBER 831361 LOT 61165, MULTIPLE CANNULAS ARE DULL AND WILL NOT PUNCTURE SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1620174 | EASYTOUCH | PEN NEEDLE | FMI | BERPU MEDICAL TECHNOLOGY CO., LTD | 61165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |