TRUEplus TRUEplus 5 bevel Pen Needle 31G/8mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00021292010799), received between Nov 9, 2020 and Sep 11, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “No Flow” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; No Flow

  Patient problems: Wheal(s)

  MAUDE report 50735663 ↗
• MalfunctionFeb 6, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT 4 OF THE PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE WAS NOT 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 24283748 ↗
• MalfunctionAug 19, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER; THE CUSTOMER WAS NOT AT HOME AT THE TIME OF THE CALL. CUSTOMER REPORTED COMPLAINT FOR INACCURATE DISPENSE, STATING THE INSULIN WAS NOT GOING THROUGH THE PEN NEEDLES AND WOULD BE DISPENSED ALL OVER THE FLOOR. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2025. 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 22841826 ↗
• MalfunctionJul 25, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ ASPIRATION OF THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT A COUPLE OF THE PEN NEEDLES DID NOT WORK WHEN SHE ATTEMPTED TO PRIME THE NEEDLE TO DISPENSE THE INSULIN. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 2 WEEKS. 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 22612884 ↗
• MalfunctionApr 21, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT OF EXPERIENCING PAIN WHEN USING AND INACCURATE DISPENSE FOR THE 31G PEN NEEDLES. THE CUSTOMER STATED THAT HE HAS BEEN USING THIS BRAND OF PEN NEEDLE FOR 5 YEARS; CUSTOMER STATED THE PEN NEEDLES WORK AS INTENDED ONLY 10% OF THE TIME. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS NOT USING COMPATIBLE 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: Pain

  MAUDE report 21874504 ↗
• MalfunctionNov 15, 2024Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER REPORTED THAT WHEN SHE OPENED THE BOX OF THE 31G PEN NEEDLES SOME OF THEM DID NOT HAVE THE NEEDLE INSIDE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE MARCH 2024. 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 20694324 ↗
• MalfunctionSep 20, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE 31G PEN NEEDLES DID NOT ASPIRATE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT 2 WEEKS. 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 20266646 ↗
• MalfunctionAug 27, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT FOR REPLACEMENT PRODUCT: INTERNAL REPORT REFERENCE (B)(4). CUSTOMER STATED HE IS STILL HAVING THE SAME ISSUE WITH THE REPLACEMENT PRODUCT NOT DISPENSING THE INSULIN. 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 20075740 ↗
• MalfunctionAug 9, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2024. 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 19949887 ↗
• InjuryJun 19, 2024Break; Break

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT ON (B)(6) 2024 WHILE ADMINISTERING HIS INSULIN THE PEN NEEDLE HAD BROKEN OFF AND BECOME STUCK IN HIS ABDOMEN. THE CUSTOMER STATED HE HAD SOUGHT MEDICAL ATTENTION AND HAD GONE TO THE ER. AT THE ER CUSTOMER WAS INFORMED THAT HE REQUIRES A SURGEON AS THE NEEDLE WAS UNABLE TO BE REMOVED. CUSTOMER STATED HE WAS TOLD THAT HIS BOWELS COULD BE PERFORATED BY THE NEEDLE. THE ER HAD REFERRED CUSTOMER TO A SURGEON, WHOM THE CUSTOMER HAS CONTACTED AND IS AWAITING AN APPOINTMENT TO BE SCHEDULED. CUSTOMER STATED HE IS LOOKING FOR COVERAGE OF HIS MEDICAL EXPENSES DUE THE SURGERY THAT HE NEEDS TO HAVE. AT THE TIME OF THE CALL THE CUSTOMER DID NOT REPORT EXPERIENCING PAIN OR BRUISING AS A RESULT OF THE NEEDLE BEING STUCK IN HIS ABDOMEN. THE PACKAGE HAD NOT BEEN OPENED OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PEN NEEDLES FOR SIX MONTHS. THE CUSTOMER IS USING COMPATIBLE A PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19567535 ↗
• MalfunctionMay 23, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD REPORTED THAT THE 31G PEN NEEDLES DID NOT DISPENSE THEIR INSULIN. CUSTOMER HAD REPORTED THEY HAD TRIED TO USE SEVERAL OF THE PEN NEEDLES (UNDISCLOSED HOW MANY). THE PACKAGE WAS NOT 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 19380905 ↗
• MalfunctionApr 12, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER HAS BEEN USING THE PRODUCT FOR A FEW DAYS. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER IS USING A TRESIBA PEN THAT IS NOT COMPATIBLE WITH THE TRUEPLUS PEN NEEDLES. CUSTOMER IS ALSO USING THE NOVOLOG FLEX PEN AND CUSTOMER WAS ADVISED THAT IT IS COMPATIBLE WITH THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED SHE WILL LET HER PHARMACIST KNOW. 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. THE LOT EXPIRATION DATE IS 07/31/2027 AND THE OPEN DATE WAS A FEW DATES PRIOR TO THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096268 ↗
• MalfunctionMar 25, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE OF THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN; CUSTOMER STATED THE ISSUE HAD OCCURRED WITH MULTIPLE PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ONE MONTH. 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 18973457 ↗
• MalfunctionMar 5, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR LESS THAN ONE MONTH. 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 DID NOT HAVE THE PRODUCT WITH HER AT THE TIME OF THE INITIAL CALL WAS UNABLE TO PROVIDE LOT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838250 ↗
• MalfunctionJan 11, 2024Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES ARE NOT DISPENSING THE INSULIN OR THEY ARE BENT. CUSTOMER STATED THAT SHE HAD 2 OTHER BOXES AND A FEW OF THEM HAD THE SAME ISSUE; CUSTOMER STATED SHE HAD DISCARDED THE BOXES (100 PEN NEEDLES EACH ONE). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PEN NEEDLES OUT OF THIS PACKAGE FOR A FEW DAYS. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. 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 18494276 ↗
• MalfunctionMar 1, 2023Positioning Problem; Positioning Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE 31G PEN NEEDLES WERE NOT ALIGNING WITH HIS COMPATIBLE PEN NEEDLE INJECTOR. CUSTOMER STATED THAT HE IS NOT ABLE TO ADMINISTER HIS INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE 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 16458946 ↗
• MalfunctionMar 15, 2021No Flow; No Flow

  CONSUMER REPORTED COMPLAINT OF INACCURATE DISPENSE FOR THE 31G PEN NEEDLES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED HE WAS UNABLE TO DEPRESS THE PLUNGER AND DISPENSE THE INSULIN. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER WAS USING COMPATIBLE PRODUCT (HUMALOG KWIKPEN) 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11488116 ↗
• MalfunctionNov 9, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. CUSTOMER STATED THAT SHE USED THE NEEDLES FOR THE PAST FEW DAYS AND ABOUT THREE OF THEM WERE BENT WHEN SHE TRIES TO ADMINISTER HER INJECTION. CUSTOMER STATES THAT WHEN SHE INSERTS THE NEEDLE IN HER STOMACH IT MOVES AROUND, AND SHE IS SCARED THAT THE NEEDLE WILL COME OFF WHILE IN HER STOMACH. CUSTOMER STATED SHE RECEIVED THE PEN NEEDLES ON 09/20/2020. CUSTOMER WAS UNABLE TO VERIFY THE LOT # OR ANY INFORMATION ON THE PACKAGE OF THE PEN NEEDLES STATING THAT THE PHARMACY GIVES HER THEM TO HER 30 AT A TIME IN A PRESCRIPTION BOTTLE. CUSTOMER STATED THAT SHE WAS GETTING THEM IN THE BOX BUT FOR THE LAST 2-3 MONTHS, THE PHARMACY REMOVES THEM AND PUTS THEM IN A PRESCRIPTION BOTTLE. CUSTOMER WAS ONLY ABLE TO VERIFY THAT THE PEN NEEDLES ARE 31 GAUGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES WAS REPORTED. PHARMACY WAS CONTACTED ON 10/14/2020 AND CONFIRMED THAT THE CUSTOMER IS ON STATE INSURANCE AND THAT ALL IT WOULD COVER IS 30 PEN NEEDLES AT A TIME. PHARMACIST STATED THAT THEY HAVE TO BREAK THE BOX AND GIV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810172 ↗