droplet® pen needles 32G x 6mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05907996093090), received between Apr 7, 2023 and Jun 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  PATIENT CALLED ON (B)(6) 2023 AT 11:59 AM. PATIENT RECEIVED 3 BOXES OF DROPLET PEN NEEDLES 32G X 6MM FROM BAKER'S PHARMACY WITH LOT C56H8. PATIENT HAS USED DROPLET PEN NEEDLES IN THE PAST, AND HE HAS NOT HAD ANY ISSUES. PATIENT CLAIMS THAT ABOUT 25%-50% OF THE PEN NEEDLES ARE BENDING. PATIENT CLAIMS THAT HE NOTICES THE BENDING BOTH AS HE IS TRYING TO INJECT HIS INSULIN AND WHEN HE IS REMOVING THE PEN NEEDLE FROM THE SKIN. PATIENT HAS USED ABOUT 28 NEEDLES OF THE LOT NUMBER SO FAR. PATIENT CLAIMS THAT SOME INSULIN WILL LEAK OUT OF THE SKIN, AND THAT SOME INSULIN WILL STICK TO THE INSULIN PEN NEEDLE WHEN REMOVING IT. PATIENT IS UNSURE IF HE IS RECEIVING HIS FULL DOSAGE OF INSULIN, AND HE CLAIMS THAT HIS BLOOD SUGAR HAS BEEN HIGHER THAN USUAL. PATIENT HAS NOT SOUGHT NOR RECEIVED MEDICAL ATTENTION FOR THE ISSUE, AND AS OF NOW, HE DOES NOT PLAN TO. PATIENT INJECTS 8-10 UNITS OF INSULIN 3 TIMES PER DAY USING THE NOVALOG FLEXPEN, AND HE INJECTS 56 UNITS OF INSULIN ONCE PER DAY USING THE TOUJEO SOLOSTAR PEN. PATIENT CLAIMS THAT HE IS ROTATING INJECTION SITES, AND THAT THE NEEDLES ARE BENDING AT EACH INJECTION SITE THAT HE SELECTS. WE ARE REPLACING THE NEEDLES, AND WE ARE EXPECTING SAMPLES.

  Patient problems: Hyperglycemia

  MAUDE report 17243677 ↗
• MalfunctionApr 7, 2023Material Fragmentation; Material Fragmentation

  "PATIENT CALLED ON (B)(6) 2023 AND LEFT A VOICEMAIL. THE PATIENT SAYS IN THE VOICEMAIL: "I RECEIVED . . . DROPLET PEN NEEDLES FROM MY PHARMACY; I GOT SIX BOXES, BUT THE ONES I TRIED--OBVIOUSLY I THINK IT'S A BAD BATCH BECAUSE THEY'RE BREAKING OFF INSIDE OF MY STOMACH. ONE OF THEM, I WAS ABLE TO PULL OUT; THE OTHER ONE, I CAN'T FIND IN THERE . . . ." SPECIALIST HAS ATTEMPTED TO REACH OUT TO THE PATIENT ON (B)(6) 2023 AT 2:40 PM BUT WAS UNABLE TO SPEAK WITH HER. UPDATE: SPECIALIST ATTEMPTED TO CONTACT PATIENT ON (B)(6) 2023 AT 2:18 P.M. THE CALL WENT TO THE PATIENT'S VOICEMAIL, WHERE SPECIALIST LEFT ANOTHER MESSAGE. SPECIALIST CALLED AGAIN ON (B)(6) 2023 AT 2:30 PM AND LEFT ANOTHER VOICEMAIL. ON (B)(6) 2023 AT 3:57 PM, SPECIALIST WAS ABLE TO SPEAK WITH THE PATIENT. PATIENT RECEIVED 6 BOXES OF DROPLET PEN NEEDLES 32G X 6MM FROM RITE-AID IN CLARKSTON, MI WITH LOT NUMBER: C59K5. PATIENT DID NOT RECEIVE ANY COUNSELING FROM THE PHARMACIST REGARDING THE DROPLET PEN NEEDLES. PATIENT HAS BEEN USING PEN NEEDLES FOR YEARS, AND SHE HAS NEVER HAD ANY SIMILAR ISSUES BEFORE. PATIENT IS UNSURE OF WHICH BRAND OF PEN NEEDLES SHE HAS USED BEFORE THIS MOST RECENT ORDER OF DROPLET PEN NEEDLES. PATIENT C

  Patient problems: Foreign Body In Patient

  MAUDE report 16699684 ↗