TRUEplus TRUEplus 3-Bevel Pen Needle 31G/6mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00021292012793), received between Mar 11, 2021 and Mar 9, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT THE PEN NEEDLES DID NOT DISPENSE HIS INSULIN. CUSTOMER STATED HE USED 3 OF THE PEN NEEDLES. CUSTOMER STATED HE HAS 2 BOXES OF 100 UNITS, 3 BEVEL 0.25MM X 6MM 31G X 1/4" WITH THE SAME LOT NUMBER; CUSTOMER STATED THAT THEY ARE TRUE PLUS PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THIS IS THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. 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 16518924 ↗
• MalfunctionFeb 3, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN. CUSTOMER STATED HE HAD THE SAME ISSUE WITH A PREVIOUS LOT - INTERNAL REPORT REFERENCE NUMBER (B)(4). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS 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 16297194 ↗
• MalfunctionApr 20, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT FIVE OF THE 31G PEN NEEDLES DID NOT DISPENSE HIS INSULIN. CUSTOMER STATED THAT HE HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR A FEW DAYS (DID NOT SPECIFY HOW LONG). CUSTOMER STATED THAT HE HAD USED 15-20 OF THE PEN NEEDLES OUT OF THE 100 THAT CAME IN THE BOX, AND THAT FIVE OF THEM DID NOT WORK AS INTENDED IN DISPENSING THE INSULIN. CUSTOMER STATED THAT HE DOES NOT HAVE THE PEN NEEDLES THAT DID NOT DISPENSE PROPERLY. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. CUSTOMER STATED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159873 ↗
• MalfunctionFeb 3, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES, STATING THAT THE 31G PEN NEEDLES WERE UNABLE TO ADMINISTER HER INSULIN DUE TO INACCURATE DISPENSE. CUSTOMER STATED THIS HAD OCCURRED WITH 10-15 PEN NEEDLES. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS NOT USING COMPATIBLE PRODUCT: CUSTOMER IS USING THE BASAGLAR PEN INJECTOR. CUSTOMER STATED THAT SHE HAS BEEN USING THE BASAGLAR PEN INJECTOR WITH THE TRUEPLUS PEN NEEDLES FOR OVER 5 YEARS, AND THAT THIS IS THE FIRST TIME SHE IS EXPERIENCING AN ISSUE. CUSTOMER WAS ADVISED TO STOP USE OF THE PEN NEEDLES AND TO CONTACT HER DOCTOR TO OBTAIN COMPATIBLE PRODUCT. CUSTOMER DECLINED TO RETURN THE REMAINING PEN NEEDLES AND TO PROVIDE HER MAILING ADDRESS. CUSTOMER STATED THAT SHE WILL CONTINUE TO USE THE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444013 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE PEN NEEDLES. CUSTOMER STATED THAT THE 31G PEN NEEDLES ARE BENT. CUSTOMER STATED SHE WAS UNSURE IF THE NEEDLE WAS BENT PRIOR TO ASPIRATING OR DISPENSING THE INSULIN. CUSTOMER STATED SHE HAD DISCARDED THE BENT PEN NEEDLES. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE STATED THE PEN NEEDLE WAS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11829029 ↗
• InjuryMay 10, 2021Break; Break

  CONSUMER REPORTED COMPLAINT FOR THE PEN NEEDLES. CUSTOMER PEN IS NOVOLOG PEN. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT WHILE ADMINISTERING HIS INSULIN ON (B)(6) 2021, THE PEN NEEDLE HAD BROKE AND HAD BECOME STUCK IN HIS SHOULDER. DAUGHTER STATED SHE HAD MANUALLY REMOVED THE NEEDLE FROM THE CUSTOMER'S SHOULDER AND THERE WAS NO SWELLING OR BLEEDING AFTER. CUSTOMER HAD CONTACTED HIS DOCTOR AND HAS AN APPOINTMENT ON (B)(6) 2021 TO ENSURE EVERYTHING IS FINE. CUSTOMER STATED THAT HIS OTHER PEN NEEDLES ARE WORKING FINE. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE WAS PROPERLY ALIGNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11803067 ↗
• MalfunctionMar 11, 2021Dull, Blunt; Dull, Blunt

  CONSUMER REPORTED COMPLAINT THAT THE 31G PEN NEEDLES WERE DULL AND NOT SHARP. CUSTOMER HAS BEEN USING THE PRODUCT FOR A FEW WEEKS. CUSTOMER STATED THAT SOME OF THE PEN NEEDLES ARE NOT SHARP ENOUGH CAUSING HER TO HAVE TO USE ANOTHER. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. THE CUSTOMER KEEPS HER SKIN TAUT WHEN INJECTING INTO HER SKIN. 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 11466393 ↗