Member's Mark pen needles 32G 4mm 32G x 4 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00078742257723), received between Sep 21, 2018 and Dec 16, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025No Flow; No Flow

  ON 12/09/2025 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER SAID HER PEN NEEDLES DO NOT PRIME THE INSULIN AND FAIL TO DISPENSE THE DURING INJECTION ATTEMPT. SHE SAID IT TAKES 2 OR THREE PEN NEEDLES BEFORE ONE WORKS. SHE SUFFERED MIS DOSING AND AT THE TIME OF INJECTION SHE WAS UNAWARE THAT SHE DID NOT RECEIVE THE REQUIRED DOSE OF INSULIN. AN ONSITE NURSE AT HER SENIOR COMMUNITY WAS ABLE TO MONITOR HER LEVELS AND NOTICED HER LEVELS GOING UP. SHE WAS ABLE TO REDUCE HER LEVELS USING A NEW NEEDLE AFTER CONSULTING ONSITE NURSE. SHE DID NOT SUFFER ANY OTHER HEALTH CONSEQUENCE AND DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION. SHE CONFIRMED SHE FOLLOWS THE IFU AND HAS BEEN USING DROPLET FOR ABOUT 6 MONTHS. CUSTOMER USES NOVALOG AND TRESIBA INJECTOR PENS. WE ARE PROVIDING REPLACEMENT SAMPLES, AND WE EXPECT TO RECEIVED CUSTOMER SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE FORM THE CUSTOMER HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814432 ↗
• MalfunctionFeb 10, 2022Material Fragmentation; Material Fragmentation

  USER HAS BEEN USING THE MM BRAND FOR 6MO WITH NO ISSUE; HOWEVER WITH THIS BOX, 1 PEN NEEDLE BROKE INTO HER INJECTION SITE. USER WAS ABLE TO REMOVE IT ON HER OWN AND NOT REQUIRED TO MEDICAL ATTENTION AFTERWARDS. USER ALSO HAD ONE PEN NEEDLE TO BEND AFTERWARDS AS WELL. USER IS ALMOST FINISHED WITH THE BOX AND HAD NO ISSUES BEFORE THESE TWO. WE DO NOT KNOW THE RX SHE IS INJECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505066 ↗
• MalfunctionApr 16, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER CALLED IN TO LET US KNOW HER PEN NEEDLE WON'T DISPENSE ALL OF THE UNITS SHE IS DIALING AT ONE TIME. SHE TAKES 36 UNITS ONCE A DAY AND HAS TO USE 4 NEEDLES OCCASIONALLY TO GET ALL OF HER INSULIN. SHE USES A XULTOPHY PEN AND SHE PRIMES EACH TIME. SHE SAYS THAT AFTER SHE INSERTS THE NEEDLE AND STARTS TO DEPRESS, IT MAKE A LOUD CLICKING NOISE AND THEN THE INSULIN STOPS. SHE HAS TO CHANGE THE NEEDLE AT THAT POINT.

  Patient problems: No Information

  MAUDE report 9966377 ↗
• MalfunctionApr 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE SEEMS TO BE NO HOLE IN THE END OF THE NEEDLE. HUSBAND CLAIMS HE CANNOT PUSH THE MEDICATION.

  Patient problems: No Information

  MAUDE report 8530392 ↗
• MalfunctionApr 18, 2019Improper Flow or Infusion; Improper Flow or Infusion

  PATIENT PUSHES THE PLUNGER AND THE DIALED UNITS IS NOT DELIVERED. SAYS ONLY HALF THE UNITS COMES OUT ~USUALLY AROUND 15-18 UNITS. WHEN THIS HAPPEN, SHE SIMPLY REPLACES THE PEN NEEDLE 'TIP' AS SHE CALLS IT USES 90-DEGREE INJECTION TECHNIQUE AS RECOMMENDED BY HER DOCTOR. INJECTS 1X PER DAY. USES LANTUS SOLOSTAR - INJECTS 37 UNITS, SHE DOES NOT REUSE HER NEEDLES, SHE HAS 12 LEFT IN THE BOX.

  Patient problems: No Information

  MAUDE report 8526754 ↗
• MalfunctionFeb 12, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS USING THE PEN NEEDLE AND IT WENT SLIGHTLY INTO THE SKIN AND BENT. HIGHLY CONCERNED ABOUT THE POTENTIAL OF PEN NEEDLES TO BREAK OFF.

  Patient problems: No Information

  MAUDE report 8330687 ↗
• MalfunctionFeb 12, 2019Material Twisted/Bent; Material Twisted/Bent

  THE INSULIN PEN DOESN'T COME OUT DUE TO BENT NON-PATIENT END. PATIENT BELIEVES SHE IS PUTTING ON CORRECTLY. SHE DOES HAVE POOR VISION, SO SHE IS UNAWARE IF THE PEN NEEDLE IS BENT PRIOR TO PUTTING ON THE PEN.

  Patient problems: No Information

  MAUDE report 8330338 ↗
• MalfunctionDec 4, 2018Material Twisted/Bent; Material Twisted/Bent

  THE NEEDLES ARE BENDING AND USER IS HAVING INSULIN FLOW ISSUES FROM THE PEN WHILE INJECTING.

  Patient problems: No Information

  MAUDE report 8128422 ↗
• MalfunctionNov 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PEN NEEDLES ARE INCREDIBLY PAINFUL WHEN THEY GO IN. WHEN THE PATIENT GOES TO INJECT, THE BUTTON IS INCREDIBLY DIFFICULT TO PUSH.

  Patient problems: No Code Available

  MAUDE report 8105072 ↗
• MalfunctionSep 21, 2018Failure to Prime; Failure to Prime

  THERE IS TROUBLE WITH LANTUS SOLOSTAR PEN. WHEN USER TRIED TO PRIME, NO MEDICINE WOULD COME IN.

  Patient problems: No Information

  MAUDE report 7897080 ↗