TRUEplus TRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00021292012809), received between Nov 22, 2020 and May 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Flow” (3 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE 31G PEN NEEDLES ARE BENDING WHEN HE INSERTS THEM AND THEY ARE NOT ASPIRATING THE INSULIN. CUSTOMER IS FEELING WELL AT THIS TIME AND IS NOT HAVING ANY DIABETIC SYMPTOMS. CUSTOMER ALSO ADVISED THAT IN THE AREA IN WHICH HE ADMINISTERS HIS INSULIN, WHEN HE IS REMOVING THE NEEDLE, IT SOMEWHAT "TEARS THE SKIN AND LEAVES A BLACK AND BLUE MARK". NO MEDICAL INTERVENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER DOES NOT RECALL HOW LONG HE HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED.

  Patient problems: Bruise/Contusion; Skin Tears

  MAUDE report 21994101 ↗
• MalfunctionApr 14, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF THE 31G PEN NEEDLE. CUSTOMER ADVISED THAT WHEN SHE ATTEMPTS TO GIVE HERSELF THE INSULIN, THE INSULIN IN NOT ASPIRATING AND DISPENSING THROUGH THE PEN NEEDLE. THE CUSTOMER WAS NOT USING COMPATIBLE PRODUCT (LISPRO INJECTION KWIK PEN). THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR A FEW WEEKS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112266 ↗
• MalfunctionDec 16, 2021No Flow; No Flow

  CONSUMER REPORTED COMPLAINT OF INACCURATE DISPENSE FOR THE 31G PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES DID NOT DISPENSE THE INSULIN WHEN READY TO BE ADMINISTERED. CUSTOMER STATED THAT THIS OCCURRED WITH TWELVE OF THE PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE WAS PROPERLY ALIGNED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018278 ↗
• MalfunctionNov 22, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER REPORTED COMPLAINT FOR PEN NEEDLES. CUSTOMER INDICATED THAT SOME OF THE PEN NEEDLES WERE DIFFERENT LENGTHS AND PER INFORMATION OBTAINED FROM THE CALL RECORDING, THE CUSTOMER HAD ALSO STATED THAT THE PEN NEEDLES WERE BENT. AT THE TIME OF THE CALL, THE CUSTOMER HAD FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER DID NOT CLAIM TO BE INJURED WHEN USING THE PEN NEEDLES AND NO MEDICAL ATTENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10882149 ↗