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droplet® pen needles 32G x 5mmRecalls & reported problems

Htl Strefa S A · 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin or drugs. · Class 2

All models of droplet pen needles (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05907996092680), received between Sep 18, 2020 and Apr 17, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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

  • Infusion or Flow Problem2
  • Material Fragmentation2
  • Dull, Blunt1
  • Fluid/Blood Leak1

Patient problems

  • Foreign Body In Patient2
  • No Clinical Signs, Symptoms or Conditions2
  • Bruise/Contusion1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 17, 2023Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

    PATIENT CALLED ON (B)(6) 2023 AT 3:55 PM. PATIENT RECEIVED 1 BOX OF DROPLET PEN NEEDLES 32G X 5MM FROM STOP AND SHOP PHARMACY WITH LOT NUMBER: C46E5. PATIENT IS NEW TO THE DROPLET BRAND, BUT SHE HAS BEEN INJECTING INSULIN FOR ROUGHLY 30 YEARS, AND SHE HAS NOT EXPERIENCED ANY SIMILAR PROBLEMS BEFORE. PATIENT CLAIMS THAT, OF 7 PEN NEEDLES THAT SHE TRIED, A COUPLE OF THE PEN NEEDLES DID NOT PIERCE HER SKIN EASILY. INSTEAD, SHE NEEDED TO PUSH ON THE INSULIN PEN WITH EXCESSIVE FORCE IN ORDER FOR THE PEN NEEDLE TO PENETRATE THE SKIN. THOSE PEN NEEDLES ALSO BENT AS SHE USED MORE FORCE TO PUSH THE NEEDLE INTO HER SKIN. POST-INJECTION, SHE CLAIMS THAT SOME INSULIN WOULD BE ON THE SURFACE OF HER SKIN RATHER THAN INSIDE OF THE SKIN, MAKING IT DIFFICULT TO TELL IF SHE HAD RECEIVED HER FULL DOES OF INSULIN OR NOT. THE PEN NEEDLES ALSO LEFT BRUISES ON HER SKIN. ONE PEN NEEDLE BROKE OFF INSIDE OF HER ABDOMEN. THE PATIENT THEN USED A RAZOR BLADE TO MAKE AN INCISION IN HER SKIN AND USE TWEEZERS TO RETRIEVE THE NEEDLE. PATIENT DID NOT SEEK OR RECEIVE MEDICAL ATTENTION, AND SHE DOES NOT PLAN TO DO SO. SPECIALIST ASKED THE PATIENT TO INFORM HIM IF SHE DECIDES TO SEEK MEDICAL ATTENTION OR IF SHE EXPERI

    Patient problems: Bruise/Contusion; Foreign Body In Patient

    MAUDE report 16751268 ↗
  • MalfunctionApr 30, 2021Infusion or Flow Problem; Infusion or Flow Problem

    THE USER INJECTS 54 UNITS OF LEVEMERE (EACH WITH CORRESPONDING PEN) 1X PER DAY. HE CALLED IN STATING THAT THE PN ARE DULL AND THEY DON'T INJECT HIS FULL DOSAGE. HE HAS TO USE BETWEEN 4-5 PEN NEEDLES EACH TIME HE INJECTS. HE DOES NOT REUSE PEN NEEDLES. THIS IS HIS 2ND COMPLAINT THIS YEAR AND 4TH OVERALL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11752036 ↗
  • MalfunctionFeb 2, 2021Dull, Blunt; Infusion or Flow Problem; Dull, Blunt; Infusion or Flow Problem

    USER INJECTS 54 UNITS OF LEVEMERE (EACH WITH THE CORRESPONDING PEN) 1X PER DAY. HE CALLED IN STATING THAT THESE PEN NEEDLE ARE DULL AND THEY DON'T INJECT HIS FULL DOSAGE EITHER. HE HAS TO USE B/T 4-5 PEN NEEDLES EACH TIME HE INJECTS. HE DOES NOT REUSE PEN NEEDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11264635 ↗
  • MalfunctionSep 18, 2020Material Fragmentation; Material Fragmentation

    PATIENT SAID THE PEN NEEDLE BREAKING OFF INTO HER BELLY 3X AND HAS ONLY BEEN USING THE PRODUCT ONE MONTH. SHE SWITCHED TO ANOTHER BRAND AND HAS NOT EXPERIENCED ANY ISSUE SO, SHE CHOSE TO DISCONTINUE THE USE OF THE DROPLET BRAND. THE PATIENT WAS ABLE TO REMOVE NEEDLES WITHOUT MEDICAL ATTENTION.

    Patient problems: Foreign Body In Patient

    MAUDE report 10552361 ↗

Other Needle, Hypodermic, Single Lumen devices

All Needle, Hypodermic, Single Lumen devices →

Sources and updates

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