FDA Adverse Event Malfunction Summary report: N

INSULIN SYRINGE

MDR report key: 18587480 · Received January 26, 2024

Report

Report Number
3014312726-2024-00181
Event Type
Malfunction
Date Received
January 26, 2024
Report Date
January 26, 2024
Manufacturer
SOL-MILLENNIUM MEDICAL INC
Product Code
FMF
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

CUSTOMER REPORTED: ON (B)(6) 2024 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT: CUSTOMER SAID SHE HAS BEEN USING DROPLET INSULIN SYRINGE 31G X 8MM. CUSTOMER SAYS THE SYRINGE WILL NOT HOLD INSULIN PAST 4CCS, NO MATTER IF SHE DRAWS 8CC OR 6CC IT ONLY RETAINS 4CC. SHE SAYS THIS IS HAPPENING FOR THE MAJORITY OF THE SYRINGES SHE HAS USED IN CURRENT BOX. SHE USES ANOTHER BRAND THROUGH WALMART THAT WAS NOT IN STOCK AT THE TIME, DECIDED TO TRY RITE-AID AND THEY RECOMMENDED DROPLET INSULIN SYRINGE 31G X 8MM. SHE SAYS SHE DOES NOT LIKE OUR PRODUCT AND WOULD LIKE A FULL REFUND. SHE SAYS SHE ROTATES INJECTION SITES AND HAS BEEN INJECTING INSULIN FOR OVER 2 YEARS. THIS WAS ALL THE INFORMATION SHE PROVIDED US, AND SHE DIDN'T STAY ON THE PHONE FOR VERY LONG, BECAUSE SHE WAS VERY UPSET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1148062 INSULIN SYRINGE SYRINGE FMF SOL-MILLENNIUM MEDICAL INC 6006 02206040

Patients

Seq Age Sex Outcome Treatment
1 Unknown