TRUEplus TRUEplus 3-Bevel Pen Needle 31G/5mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00021292012786), received between Jul 24, 2020 and Feb 1, 2023 — classified as 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED THAT THE 31G PEN NEEDLES DID NOT ASPIRATE THE INSULIN FROM THE VIAL. CUSTOMER STATED THAT THIS ISSUE OCCURRED WITH 25 OUT OF 100 OF THE PEN NEEDLES. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. 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. CUSTOMER DECLINED TO RETURN THE PEN NEEDLES TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280249 ↗
• MalfunctionSep 14, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT SOME OF THE 31G PEN NEEDLES WERE NOT ASPIRATING. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PEN INJECTORS WITH THE PEN NEEDLES. CUSTOMER ADVISED THAT HE ONLY HAS ONE PEN NEEDLE LEFT. 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 STATING THAT OUT OF HIS BOX OF PEN NEEDLES, HE HAD SOME THAT WERE NOT ASPIRATING. CUSTOMER IS FEELING WELL AT THIS TIME AND IS NOT HAVING ANY DIABETIC SYMPTOMS. NO ADVERSE EVENTS REPORTED WITH THE USE OF THE PRODUCT. CUSTOMER IS USING COMPATIBLE PEN INJECTORS WITH THE PEN NEEDLES. CUSTOMER ADVISED THAT HE ONLY HAS ONE NEEDLE LEFT. ADVISED CUSTOMER THAT I WOULD SEND OUT A PREPAID ENVELOPE FOR HIM TO SEND BACK THE PEN NEEDLE. ADVISED CUSTOMER TO CONTACT HIS PHARMACY FOR ANY REPLACEMENTS. WILL FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418559 ↗
• MalfunctionJul 2, 2021Component Missing; No Flow; Component Missing; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE 31G TRUEPLUS PEN NEEDLES. THE CUSTOMER STATED WHEN SHE WENT TO USE ONE OF THE PEN NEEDLES, IT DID NOT ASPIRATE/DISPENSE HER INSULIN. THE CUSTOMER STATED THAT THE PART OF THE PEN NEEDLE WAS MISSING; CUSTOMER HAD STATED THE FRONT PART OF THE NEEDLE WAS THERE, BUT THE BACK PART THAT CONNECTS TO HER NOVOLOG FLEX PEN WAS NOT THERE. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR A FEW WEEKS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE WAS ALIGNED PROPERLY. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE 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 12107474 ↗
• MalfunctionOct 23, 2020No Flow; No Flow

  CONSUMER COMPLAINT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM (MW5096220). CONSUMER REPORTED COMPLAINT FOR PEN NEEDLE NOT DISPENSING CORRECT AMOUNT OF INSULIN AND THE BLOOD SUGAR ELEVATED DUE TO THE DOSE NOT BEING ADMINISTERED CORRECTLY. THE CUSTOMER DID NOT REPORT SYMPTOMS AND MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE PRODUCT USE. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURERS EXPIRATION DATE IS 08/31/2021 AND OPEN VIAL DATE IS UNDISCLOSED. EVENT DESCRIPTION - MEDWATCH: PT STATES THAT NEEDLE ATTACHED TO INSULIN PEN BUT SHE CANNOT PUSH INSULIN THROUGH PEN HER BLOOD SUGAR WERE ELEVATED DUE TO DOSE NOT BEING ADMINISTERED CORRECTLY. PT HAS BEEN INJECTING INSULIN PEN QUITE AWHILE AND HAS NEVER HAD AN ISSUE IN THE PAST. PT HAS BEEN A DIABETIC FOR MANY YEARS. SHE HAS BEEN USING THIS PRODUCT FOR YEARS. THIS PARTICULAR TIME SHE HAD TROUBLE WITH INJECTING HER LANTUS INSULIN. THE PEN NEEDLE ATTACHED TO THE INSULIN PEN FINE, BUT THE INSULIN WOULD NOT INJECT THROUGH THE NEEDLE. SHE TRIED SEVERAL PEN NEEDLES WITHOUT SUCCESS. HER BLOOD SUGAR HAS BEEN ELEVATED DUE TO THE INABILITY TO RECEIVE THE DOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731408 ↗
• MalfunctionSep 15, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT AND WARPED PEN NEEDLE. THE CUSTOMER DID REPORT NEEDLES STICK AND BRUISING. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2021 AND OPEN VIAL DATE IS (B)(6) 2020.

  Patient problems: Bruise/Contusion; Needle Stick/Puncture

  MAUDE report 10535149 ↗
• MalfunctionJul 24, 2020Break; Break

  CONSUMER REPORTED COMPLAINT FOR BROKEN PEN NEEDLES. ACCESS HEALTH LA PHARMACY REPRESENTATIVE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 08/3/2024 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323511 ↗