Pen Needle 681131386807Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00681131386807), received between Mar 26, 2021 and Jun 3, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. LOT #: 3335137 CATALOG #: 320617 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134125 ↗
• MalfunctionMar 20, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG WHEN PRIMING THE PEN NEEDLES. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653029 ↗
• MalfunctionOct 17, 2024Failure to Deliver; Failure to Deliver

  LOT: 3126871, (TWO BOXES WITH SAME LOT). CATALOG: 6MMX31 PEN NEEDLES,(BOX WAS DISCARDED). DATE OF EVENT: UNKNOWN. SAMPLES: NO. REPORTED PEN NEEDLE CLOG WITH TWO BOXES. STATED, OVER 10 PEN NEEDLES AFFECTED FROM EACH BOX. STATED, NO INSULIN FLOW WHEN TAKING INJECTIONS. STATED, HE DOES NOT TEST HIS PEN NEEDLES BEFORE TAKING INJECTIONS. REPLACEMENT ONLY. CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471235 ↗
• MalfunctionAug 27, 2024Misconnection; Misconnection

  FAMILY MEMBER OF CONSUMER REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE INSULIN PEN. I REVIEWED THE STEPS WITH CONSUMER AND SHE WAS ABLE TO SECURE THE NEEDLE ONTO THE PEN. CONSUMER IS NEW TO USING PEN NEEDLES. LOT #: 3096247, CATALOG #: 320617, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078776 ↗
• MalfunctionMay 23, 2024Defective Device; Defective Device

  CONSUMER REPORTED PLACES THE PEN NEEDLE ON HIS KWIK PEN LILLY. THEN REMOVES OUTER AND INNER SHIELD. NOTICED 2 PEN NEEDLES WITHOUT THE PATIENT END NEEDLES. CONSUMER REPORTED THE SAME 2 PEN NEEDLES THAT WERE MISSING HE COULD NOT REMOVE FROM THE KWIK PEN. HAD TO DISCARD HIS 2 PENS. INFORMED CALLER TO CONTACT LILLY WITH THIS ISSUE - DC LOT # 3096247 CATALOG# 320617 DATE OF EVENT 04.30.2024 DATE OF EVENT 05.01.2024 SAMPLE STATUS DISCARD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387578 ↗
• MalfunctionMay 23, 2024Defective Device; Defective Device

  CONSUMER REPORTED PLACES THE PEN NEEDLE ON HIS KWIK PEN LILLY. THEN REMOVES OUTER AND INNER SHIELD. NOTICED 2 PEN NEEDLES WITHOUT THE PATIENT END NEEDLES. CONSUMER REPORTED THE SAME 2 PEN NEEDLES THAT WERE MISSING HE COULD NOT REMOVE FROM THE KWIK PEN. HAD TO DISCARD HIS 2 PENS. INFORMED CALLER TO CONTACT LILLY WITH THIS ISSUE - DC. LOT # 3096247; CATALOG# 320617; DATE OF EVENT 04.30.2024; DATE OF EVENT 05.01.2024; SAMPLE STATUS DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387571 ↗
• MalfunctionAug 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT 2 OF THE RELION® PEN NEEDLES DETACHED WHEN REMOVING THE OUTER COVER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED 2 BOXES FINDING WHEN REMOVING THE OUTER COVER FROM PEN NEEDLE, THE NEEDLE REMOVES WITH THE OUTER COVER OF THE PEN NEEDLE. INFORMED OF PROPER PLACEMENT OF THE NEEDLE TO PEN AND TO PULL OUTER COVER AWAY FROM THE NEEDLE AND NOT TO TURN IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633017 ↗
• MalfunctionJul 6, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT WHILE USING THE BD PEN NEEDLE IT WAS CLOGGED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276133 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Failure to Deliver; Fluid/Blood Leak; Failure to Deliver

  IT WAS REPORTED THAT DURING USE WITH RELION PEN NEEDLES 6MM X 31 GAUGE (15/64" X 0.25MM) PEN NEEDLES THE INSULIN LEAKED AND THE FULL DOES WAS NOT DELIVERED. PATIENTS GLUCOSE WAS ELEVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT INSULIN LEAKS FROM THE NEEDLES AFTER INJECTION. CONSUMER ALSO REPORTED THAT HIS GLUCOSE LEVEL IS ELEVATED AND HE IS NOT SEEING THE NUMBERS THAT HE EXPECTS AFTER INJECTION. I ADVISED CONSUMER TO CONSULT WITH HIS DOCTOR REGARDING THE ELEVATED GLUCOSE LEVEL.

  Patient problems: Hyperglycemia

  MAUDE report 17121330 ↗
• MalfunctionMay 25, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE RELION® PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN TAKING INJECTION, NO INSULIN FLOWS. CONSUMER DOES NOT PRIME BEFORE TAKING INJECTION. STATED, HE'S WASTED A LOT OF PEN NEEDLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007750 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED WHILE USING RELION PEN NEEDLES 6MM X 31 GAUGE THE NEEDLE BROKE. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PATIENT END IS BREAKING WHENEVER SHE INJECTS IN HER STOMACH STATED, SOMETIMES PATIENT END WILL BREAK OFF IN BUTTOCKS DID NOT SEEK MEDICAL. LOT: 1308258. CATALOG: 320617. DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709961 ↗
• MalfunctionNov 17, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE RELION® PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 NEEDLE CLOGGED WHILE INJECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820725 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT THE RELION® PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 NEEDLE CLOGGED WHILE INJECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795150 ↗
• MalfunctionMay 5, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE RELION PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. STATED, NO INSULIN FLOW WHEN PRIMING"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14293187 ↗
• MalfunctionMar 24, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 RELION INSULIN SYRINGES WERE UNABLE TO DELIVER MEDICATION AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED SEVERAL DEVICES TO CLOG DURING INJECTION AND WAS PUSHING THE NEEDLE HARD ONTO THE PEN BUT DID NOT SCREW ONTO THE PEN. FURTHERMORE THEY DID NOT TO WORK DURING FLOW CHECK. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889927 ↗
• MalfunctionMar 12, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT 1 RELION INSULIN SYRINGE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE CLOG DURING INJECTION STATING THAT THE PEN STOPS AFTER A FEW UNITS. THE CONSUMER DOES NOT PRIME. DATE OF EVENT : UNKNOWN. SAMPLES : DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743891 ↗
• MalfunctionFeb 28, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT 2 RELION INSULIN SYRINGES HAD SHIELD AND OUTER COVER ATTACHMENT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE COVERS ARE DIFFICULT TO REMOVE AFTER ATTACHING THE HUB TO THE INSULIN PEN. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620812 ↗
• MalfunctionFeb 16, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHEN USING THE RELION® PEN NEEDLE, THE USER EXPERIENCED THE INABILITY TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CONSUMER REPORTED FINDING 6-8 PEN NEEDLES PER BOX SINCE NOVEMBER THAT CLOG DURING INJECTION. I DON'T COMPLETE THE FLOW CHECK. THE PEN NEEDLES CHANGED MANUFACTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545930 ↗
• MalfunctionJan 5, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 PN RELION 31G X 6MM 3B TW WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT 3 PEN NEEDLES CLOGGED DURING INJECTION. DATE OF EVENT: (B)(6) 2021; SAMPLES STATUS: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172307 ↗
• MalfunctionNov 30, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AT LEAST 2 BD 6MM RELION PEN NEEDLES WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. STATED, SHE'S BEEN HAVING THE ISSUES ON AND OFF FOR ONE YEAR WITH DIFFERENT BOXES BUT THIS IS THE FIRST TIME REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906090 ↗
• MalfunctionSep 24, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 1 BD PN RELION 31G X 6MM WAS UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE PATIENT END OF NEEDLE WAS MISSING AND THERE WAS NO INSULIN FLOW DURING INJECTION. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525664 ↗
• MalfunctionAug 23, 2021Misconnection; Misconnection

  IT WAS REPORTED THAT 1 BD PN RELION 31G X 6MM WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED FINDING THE NEW RELION PEN NEEDLES DIFFICULT TO ATTACH TO THE PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354354 ↗
• MalfunctionJul 28, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PN RELION 31G X 6MM WAS UNABLE TO DELIVER INSULIN, AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELION PHARMACIST AND CONSUMER CALLED IN. CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. STATED, HE PRIMES 2 TO 3 UNITS. STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, HE'S USING 2 OR 3 PEN NEEDLES TO COMPLETE ONE INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242878 ↗
• MalfunctionJul 14, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PN RELION 31G X 6MM 3B WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 1 PEN NEEDLE TO CLOG DURING INJECTION. DOES NOT COMPLETE FLOW CHECK BEFORE INJECTIONS. CHANGED THIS PEN NEEDLE FROM BASLAGAR PEN AND COMPLETED INJECTIONS WITH ANOTHER PEN NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170399 ↗
• MalfunctionJul 12, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PN RELION 31G X 6MM 3B TW EXPERIENCED AN OUTER COVER THAT WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, HE COULD NOT REMOVE THE OUTER COVER PRIOR TO INJECTION. STATED, HE HAD TO USE A SECOND PEN NEEDLE AND THAT WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155870 ↗