TRUEplus TRUEplus STERILE pen needles 32 GAUGE x 5/32"Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00021292009076), received between Sep 25, 2019 and Aug 20, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2021Improper Flow or Infusion; Improper Flow or Infusion

  CUSTOMER STATE THAT THE NEEDLE ARE NO GOOD. CUSTOMER STATES THAT THE NEEDLES WOULD JUST STOP HALFWAY WHEN SHE TRIES TO ADMINISTER HER INSULIN . THE INSULIN WOULD JUST STOP HALF WAY. VERIFY CUSTOMER IS NOT USING A COMPATIBLE INJECTOR BASAGLAR KWIK PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346501 ↗
• MalfunctionMay 18, 2020No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF THE TRUEPLUS PEN NEEDLES. WIFE CALLED ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE INSULIN IS NOT BEING FULLY ASPIRATED. THE PACKAGE WAS NOT OPENED OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR ABOUT A WEEK. CUSTOMER FELT WELL AND WAS NOT HAVING ANY DIABETIC SYMPTOMS. NO ADVERSE EVENTS HAS BEEN REPORTED. CUSTOMER WILL DISCONTINUE USE OF THE PRODUCT AND GO BACK TO THE PHARMACY FOR A REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067507 ↗
• MalfunctionMay 5, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT REPORT ANY ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER DID NOT RECALL WHEN SHE HAD FIRST USED THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025772 ↗
• MalfunctionApr 7, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT AND DULL PEN NEEDLES. THE CUSTOMER DID REPORT SYMPTOMS OF BLEEDING- CREATING LUMPS ON SKIN. CUSTOMER IS USING COMPATIBLE INSULIN PEN, HUMALOG PEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 09/01/2023 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: Skin Irritation

  MAUDE report 9933053 ↗
• MalfunctionJan 14, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. ADVOCATE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED SHE WAS UNABLE TO HER TAKE HER INSULIN BECAUSE A LOT OF THE PEN NEEDLES WERE BENT. CUSTOMER STATED THE PEN NEEDLES HAD BEEN BENT WHEN SHE HAD OPENED THE BOX. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT NEED MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587445 ↗
• MalfunctionJan 8, 2020No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION. CUSTOMER WAS CONCERNED THAT THE PEN NEEDLES WERE NOT DISPENSING HER INSULIN. CUSTOMER STATED THAT THE ISSUE OCCURRED WITH SEVEN PEN NEEDLES - TWO THIS MORNING AND FIVE EARLIER IN THE WEEK. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT NEED MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565102 ↗
• MalfunctionSep 25, 2019Improper Flow or Infusion; Improper Flow or Infusion

  CONSUMER REPORTED COMPLAINT FOR PEN NEEDLE INACCURATE DISPENSE/ASPIRATION, STATING THAT SOME OF THE PEN NEEDLES ARE NOT DISPENSING INSULIN. CUSTOMER HAD CONCERNS THAT THE PRODUCT IS UNABLE TO ADMINISTER THEIR INSULIN DUE TO THE ISSUE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS OR THAT MEDICAL ATTENTION HAD BEEN REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120686 ↗