Member's Mark pen needles 31G 8mm 31G x 8 mmRecalls & reported problems
Wal-Mart Stores, Inc. · Sterile, single use pen needles. Intended to be used with pen injector device for the subcutaneous injection of insulin. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00078742257754), received between Aug 13, 2018 and Feb 18, 2021 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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
Device problems
- Dull, Blunt3
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Material Fragmentation1
- Material Integrity Problem1
- Material Twisted/Bent1
- Obstruction of Flow1
Patient problems
- No Information6
- Missing Value Reason1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2021Material Fragmentation; Material Fragmentation
THE PATIENT CALLED IN TODAY BECAUSE, HER PEN NEEDLE KEEP BREAKING OFF INTO HER BELLY. SHE HAS BEEN INJECTING FOR 4 YEARS AND THIS HAS NEVER HAPPENED. SHE WAS SWITCHED FROM OTHER MARK TO DROPLET LAST MONTH. SHE WENT THROUGH ABOUT HALF OF THE 1ST BOX AND HAD 20 PN BREAK OFF INTO HER BELLY SO, SHE THREW THE BOX AWAY THINKING THE BOX WAS DEFECTIVE. SHE'S BEEN USING THE 2ND BOX A COUPLE DAYS AND HAS ENCOUNTERED THE SAME ISSUES. SHE DOES NOT REUSE PN. WE WENT OVER HER TECHNIQUE AND IT SEEMS LIKE SHE IS INJECTING PROPERLY; HOWEVER, SHE DID HAVE HERNIA SURGERY AROUND THE AREA SHE INJECTS SO, THERE COULD BE SCAR TISSUE. THE BROKEN PEN NEEDLES REMOVED BY PATIENT VIA TWEEZERS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11341607 ↗MalfunctionDec 20, 2019Material Integrity Problem; Material Integrity Problem
USER BOUGHT (4) BOXES OF MM 31G X 8MM PEN NEEDLES WITH LOT NO. Y46ZC2. HE INJECTS 5-10 UNITS OF HUMALOG ON A SLIDING SCALE 1X PER DAY WITH THE CORRESPONDING PEN. HE CALLED BECAUSE HIS PN IS BREAKING INSIDE THE PEN SOMEHOW. THIS HAS HAPPENED SEVERAL TIMES. WIFE WAS ABLE TO PUSH ONE PN TIP OUT OF THE PEN BY PRESSING REALLY HARD BUT, THE OTHERS COULD NOT BE REMOVED WHICH MAKES THE ACTUAL PEN USELESS.
Patient problems: Missing Value Reason
MAUDE report 9503027 ↗MalfunctionFeb 21, 2019Obstruction of Flow; Obstruction of Flow
WIFE CALLING ON BEHALF OF HUSBAND. THE LAST BOX HAD 9 PEN NEEDLES WOULD NOT INJECT INSULIN.
Patient problems: No Information
MAUDE report 8357054 ↗MalfunctionJan 21, 2019Dull, Blunt; Dull, Blunt
PATIENT SAYS NEEDLES ARE DULL. SHE'S NOT ABLE TO PENETRATE SKIN EASILY. SHE'S HAD TO APPLY TOO MUCH FORCE AND HER SKIN IS BRUISING.
Patient problems: No Information
MAUDE report 8263733 ↗MalfunctionNov 16, 2018Dull, Blunt; Dull, Blunt
MalfunctionNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT IS COMPLAINING THE NEEDLES ARE VERY PAINFUL WHEN INJECTING.
Patient problems: No Code Available
MAUDE report 8077270 ↗MalfunctionNov 16, 2018Material Twisted/Bent; Material Twisted/Bent
PATIENT SAYS THAT EVERY OTHER NEEDLE BENDS WHEN INJECTING MEDICATION.
Patient problems: No Information
MAUDE report 8077143 ↗MalfunctionNov 16, 2018Dull, Blunt; Dull, Blunt
THE NEEDLES ARE DIFFICULT TO PENETRATE THE SKIN AND A POP IS HEARD. PATIENT ALSO COMMENTED THAT THE NEEDLE DOES NOT FEEL SMOOTH WHEN INSERTING/PULLING OUT THE NEEDLE.
Patient problems: No Information
MAUDE report 8077122 ↗MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER HAS HAD SEVERAL PEN NEEDLES THAT HE SAYS WERE DEFECTIVE. A FEW WERE BENT AND HE STILL INJECTED. THEN HE SAVED 3 THAT WERE DEFECTIVE AND BENT INTO A Z.
Patient problems: No Information
MAUDE report 7776169 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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