TRUEplus TRUEplus Sterile Pen NeedlesRecalls & reported problems
Trividia Health, Inc. · TRUEplus Pen Needles 32G x 5/32" · Class 2
All models of TRUEplus (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292010317), received between Jun 14, 2021 and Aug 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper Flow or Infusion1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2021Improper Flow or Infusion; Improper Flow or Infusion
CUSTOMER CALLED BECAUSE HER PEN NEEDLES ARE NOT DISPENSING THE INSULIN PROPERLY . CUSTOMER STATES THAT SOME OF HER PEN NEEDLES ARE NOT DISPENSING HER INSULIN ACCURATELY. CUSTOMER DID NOT SEEK ANY MEDICAL ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12341627 ↗MalfunctionJun 14, 2021No Flow; No Flow
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES, STATING SOME OF THE 32G PEN NEEDLES DID NOT ACCURATELY DISPENSE HER INSULIN. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER STATED SHE HAD DISCARDED THE ALLEGED DEFECTIVE PEN NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11992395 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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