TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 5/16"Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00021292009069), received between Sep 6, 2018 and Mar 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. 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 11/01/2023. CUSTOMER WILL HOLD ON TO 10 OF THE PEN NEEDLES TO SEND BACK TO US AND WILL GO TO HER LOCAL PHARMACY TO SEEK A REPLACEMENT. CUSTOMER HAS THE FLEXTOUCH AND THE KWIK PEN. CUSTOMER WAS INFORMED THAT THE FLEX TOUCH IS NOT A COMPATIBLE DEVICE. CUSTOMER STATES SHE HAD THE ISSUE WITH BOTH INJECTORS. CUSTOMER STATES SHE DOES NOT BELIEVE THAT SHE GOT THE CORRECT DOSAGE OF INSULIN THAT DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871408 ↗
• MalfunctionDec 23, 2019Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. PHARMACY IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE PEN NEEDLES WOULD BEND WHEN SHE ATTEMPTED TO INJECT HER INSULIN. CUSTOMER WAS CONCERNED THAT THE PRODUCT WAS UNABLE TO ADMINISTER HER INSULIN DUE TO THE BENT NEEDLES. CUSTOMER STATED THAT THIS WAS FIRST TIME SHE USED THE PRODUCT OUT OF THE PACKAGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER WAS NOT CLAIMING SHE WAS INJURED AND DID NOT NEED ANY MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES. CUSTOMER IS USING A COMPATIBLE LANTUS SOLAR STAR PEN WITH HER PEN NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513152 ↗
• MalfunctionSep 6, 2018Failure to Eject; Failure to Eject

  CONSUMER REPORTED COMPLAINT FOR NEEDLE STICK DUE TO THE PEN NEEDLE BEING STUCK ON THE PEN. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. CUSTOMER CALLED IN STATES HE IS UNABLE TO TAKE THE PEN NEEDLE OF THE INJECTOR. CUSTOMER STATES HE PUT THE CLEAR PROTECTIVE CAP AND IT DOES NOT COME OFF WHEN HE PULLS IT OFF. CUSTOMER STATES HE HAD A NEEDLE STICK DUE TO THE PEN NEEDLE BEING STUCK ON THE PEN. CUSTOMER HAS A COMPATIBLE QUICK PEN WHICH IS ON OUR APPROVED LIST. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852290 ↗