Member's Mark pen needles 31G 6mm 31G x 6 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00078742257747), received between Dec 13, 2017 and May 12, 2021 — classified as 7 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
Device problems
- Material Twisted/Bent3
- Infusion or Flow Problem2
- Dull, Blunt1
- Failure to Deliver1
- Material Deformation1
- No Flow1
Patient problems
- No Code Available2
- No Information2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2021Infusion or Flow Problem; Infusion or Flow Problem
CUSTOMER CALLED STATING THAT HI PEN NEEDLES ARE CLOGGED. HE IS UNABLE TO PRIME THEM. HE DOES NOT REUSE PEN NEEDLES. HE STATES THAT THIS HAPPENED A FEW TIMES LAST MONTH WITH HIS BOXES BUT, THIS MONTH HE HAS GONE THROUGH 1/2 THE BOX AND MOST ARE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11811214 ↗MalfunctionSep 27, 2019Material Deformation; Material Deformation
USER INJECTS INSULIN AND METFORMIN 4-5X DAILY FOR ABOUT 23 YEARS. SHE COMPLAINTS THAT THIS HAS BEEN HAPPENING FOR A WHILE THAT 'THE NEEDLES 'BEND SOMETIMES, ABOUT 2-4 [NEEDLES PER BOX]'. WHEN THEY BEND, 'IT IS THE BOTTOM PART OF THE PEN NEEDLE HUB' WHICH IS BENT BEFORE PLACING NEEDLE ONTO THE PEN. ALSO ONE NEEDLE WAS BROKEN OFF IN THE PEN AND IT WAS PUSH DOWN INSIDE THE MEDICINE VIAL WHEN USER HAD PUT A NEW NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9127361 ↗MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent
PEN NEEDLES DO NOT FEEL SHARP AND DO NOT EASILY PUNCTURE THE SKIN AND BEND EASILY.
Patient problems: No Information
MAUDE report 8614545 ↗MalfunctionFeb 21, 2019Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent
PATIENT REPORTS DIFFICULTY INJECTING IN THE LAST 2 BOXES. THE PEN NEEDLES WOULD BEND UPON INJECTING AND SEVERAL WOULD NOT PUNCTURE THE SKIN. PATIENT ALSO REPORTS BRUISING AT THE INJECTION.
Patient problems: No Code Available
MAUDE report 8357107 ↗MalfunctionFeb 11, 2019Material Twisted/Bent; Material Twisted/Bent
MalfunctionAug 13, 2018Infusion or Flow Problem; Infusion or Flow Problem
USER COMPLAINT THAT SHE INJECTS HERSELF TWICE DAILY, HUSBAND INJECTS ONCE DAILY. EVERY FEW PEN NEEDLES, THE INSULIN DOES NOT COME OUT. SHE IS PRIMING THE PEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7776066 ↗MalfunctionDec 13, 2017Failure to Deliver; No Flow; Failure to Deliver; No Flow
(B)(6) CALLED (B)(6) 2017 AT APPROX. 3:20PM AND LEFT A VOICEMAIL. (B)(6) HAD RECENTLY CONVERTED FROM EASY TOUCH TO THE MEMBERS MARK PEN NEEDLES. (B)(6) EXPLAINED THAT SHE WAS INSERTING THE DROPLET PEN NEEDLES INTO HER HUMALOG KWIKPEN, FOLLOWING THE INSTRUCTIONS PROVIDED WITH THE PRODUCT. HOWEVER, SOMEHOW THE INTERIOR NEEDLE THAT GOES INTO THE INSULIN VIAL WAS SOMEHOW BECOMING BENT AND NOT DELIVERING HER INSULIN. SHE REPORTED THAT SHE HAD THAT EXPERIENCE WITH 4 PEN NEEDLES.
Patient problems: No Code Available
MAUDE report 7111809 ↗
Other Needle, Hypodermic, Single Lumen devices
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- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- 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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