TRUEplus TRUEplus Pen Needles 31 GAUGE x 3/16"Recalls & reported problems
Trividia Health, Inc. · LEADER TRUEplus Pen Needles 31 GAUGE x 3/16" · Class 2
All models of TRUEplus (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00096295129106), received between Dec 17, 2019 and Dec 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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 18, 2026.
Most reported problems
Device problems
- Incomplete or Missing Packaging1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2019Incomplete or Missing Packaging; Material Integrity Problem; Incomplete or Missing Packaging; Material Integrity Problem
CONSUMER REPORTED COMPLAINT THAT SOME OF THE TRUE PLUS PEN NEEDLES ARE MISSING THE NEEDLE. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. MOTHER ALSO STATED THAT AFTER CUSTOMER ADMINISTERS HIS INSULIN, THE NEEDLE FEELS LIKE A FISH HOOK IS COMING OUT OF HIS SKIN, AND THE NEEDLES HAVE BURRS ON THEM. CUSTOMER IS NOT CLAIMING THEY WERE INJURED OR HAD A NEGATIVE REACTION FROM USING THE SHARP. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE SHARP WAS REPORTED. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MOTHER IS NOT SEEKING REPLACEMENT, JUST CALLING TO HAVE COMPLAINT DOCUMENTED. REQUESTED CUSTOMER SEND SOME OF THE PEN NEEDLES BACK FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9481372 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page