FDA Adverse Event Malfunction Summary report: N

PEN NEEDLE 31G 5MM 3/16 UF

MDR report key: 24931684 · Received April 20, 2026

Report

Report Number
MW5187012
Event Type
Malfunction
Date Received
April 20, 2026
Report Date
April 14, 2026
Manufacturer
EMBECTA MEDICAL II LLC
Product Code
FMI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
003
Health Professional
N

Narratives

Description of Event or Problem · 0

INDICATION: AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE. PATIENT REPORTS OF WORSENING PAIN IN THE BACK OF HER KNEE SINCE LAST DISPENSE. PATIENT STATED SHE HAS HAD KNEE PAIN FOR A WHILE (EXACT DATE OF ONSET NOT PROVIDED.) BUT IT HAS WORSENED IN THE PAST MONTH. KNEE PAIN TYPICALLY OCCURS AT NIGHT AND PATIENT ADMINISTERS HER INJECTION IN THE EVENING. PATIENT ALSO STATED THAT SHE HAS HAD RECENT TROUBLE REMOVING PEN NEEDLES FROM THE PEN. SHE HAS ALWAYS REPLACED THE CAP AND TWISTED THE NEEDLE OFF, BUT THE NEEDLES SHE RECEIVED RECENTLY HAVE BEEN DIFFICULT TO REMOVE. UNKNOWN IF PEN AND/OR NEEDLES ARE AVAILABLE FOR RETURN. NO ADVERSE EVENT(S) OR MISSED DOSE(S) REPORTED DUE TO ISSUE WITH PRODUCT(S). PATIENT WILL NOTIFY PRESCRIBER REGARDING KNEE PAIN. NO FURTHER INFO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
13713 PEN NEEDLE 31G 5MM 3/16 UF NEEDLE, HYPODERMIC, SINGLE LUMEN LLC FMI EMBECTA MEDICAL II LLC

Patients

Seq Age Sex Outcome Treatment
1 NA Female