Member's Mark pen needles 31G 5mm 31G x 5 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00078742257730), received between Sep 17, 2018 and Jan 21, 2019 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (4 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, Blunt4
- Material Twisted/Bent3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Information6
- No Code Available2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2019Material Twisted/Bent; Material Twisted/Bent
PATIENT HAD 10 PEN NEEDLES OUT OF A BOX OF 100 WERE BENT ON THE NON-PATIENT END. PATIENT DID NOT NOTICE IF IT WAS HAPPENING PRIOR TO PUTTING THE PEN NEEDLE ON THE PEN.
Patient problems: No Information
MAUDE report 8263564 ↗MalfunctionJan 2, 2019Dull, Blunt; Dull, Blunt
PATIENT SAYS THE NEEDLES FEEL DULL. PATIENT AND PARTNER BOTH USE THE PRODUCT AND BOTH HAVE THE ISSUE OF HAVING TO USE EXTREME FORCE TO PUNCTURE THE SKIN.
Patient problems: No Information
MAUDE report 8207983 ↗MalfunctionDec 7, 2018Dull, Blunt; Dull, Blunt
OTHER PRODUCT "GLIDE" THROUGH THE SKIN. THE MEMBER'S MARK PRODUCT DOES NOT. PATIENT FEELS THAT SHE HAS TO PUNCH THROUGH THE SKIN.
Patient problems: No Information
MAUDE report 8140921 ↗MalfunctionNov 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT SAYS THE PEN NEEDLE STINGS WHEN INJECTING. ALSO, THE PEN NEEDLE IS LEAKING DURING INJECTION AND WHEN THE PEN NEEDLE IS BEING UNSCREWED.
Patient problems: No Code Available
MAUDE report 8077204 ↗MalfunctionNov 14, 2018Material Twisted/Bent; Material Twisted/Bent
PEN NEEDLES HURT AND THE NEEDLES ARE BENDING. SOMETIMES THERE IS A TINY BUMP AFTER PATIENT REMOVES THE NEEDLE. SHE RUBS IT AND THE BUMP DISAPPEARS IN A FEW HOURS.
Patient problems: No Code Available
MAUDE report 8068809 ↗MalfunctionSep 20, 2018Dull, Blunt; Dull, Blunt
THE PEN NEEDLES FEEL DULL AND HAVING DIFFICULTY TO INJECT.
Patient problems: No Information
MAUDE report 7893093 ↗MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT IS HAVING ISSUES REMOVING THE PEN NEEDLE FROM HER INSULIN PEN. CUSTOMER HAS NOT BEEN INJURED.
Patient problems: No Information
MAUDE report 7884783 ↗MalfunctionSep 17, 2018Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent
CUSTOMER IS HAVING AN ISSUE WITH THE NEEDLES BENDING. HE ALSO STATED HE HAS TO PRESS VERY HARD FOR THE NEEDLES TO PENETRATE HIS SKIN.
Patient problems: No Information
MAUDE report 7880523 ↗
Other Needle, Hypodermic, Single Lumen devices
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- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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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