Unifine Pentips Plus AN 3850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384703850019), received between Aug 27, 2018 and Feb 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K152339); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2022Material Separation; Material Separation

  PATIENT CALLED IN TO REPORT THAT A NEEDLE BROKE OFF IN HER ABDOMEN WHILE GIVING HERSELF HER INSULIN SHOT. SHE REPORTED SHE PULLED IT OUT HERSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529306 ↗
• InjuryFeb 14, 2022Material Separation; Material Separation

  PATIENT CALLED IN TO REPORT THAT A NEEDLE BROKE OFF IN HER ABDOMEN WHILE GIVING HERSELF HER INSULIN SHOT. SHE REPORTED SHE PULLED IT OUT HERSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529265 ↗
• InjuryAug 27, 2018Separation Problem; Separation Problem

  PATIENT'S DOCTOR CALLED ON (B)(6) 2018 STATING THE PATIENT CAME INTO HIS OFFICE A COUPLE OF DAYS EARLIER WITH A PEN NEEDLE THAT HAD BROKEN OFF INTO HIS STOMACH DURING AN INJECTION OF INSULIN. THE DOCTOR WAS INSTRUCTED TO HAVE THE PATIENT CALL DIRECTLY TO OBTAIN THE MEDICAL INFORMATION, AS THEY COULD NOT RELEASE IT. PATIENT CALLED AND REPORTED THE DOCTOR SENT HIM TO THE HOSPITAL FOR X-RAYS. TEH DOCTOR DECIDED TO WATCH THE AFFECTED AREA FOR RENESS, BRUISING AND POSSIBLE MOVEMENT OF THE NEEDLE. THE PATIENT WAS TOLD IT WOULD HAVE TO BE SURGICALLY REMOVED. THE PEN NEEDLE HUB THE NEEDLE BROKE OFF HAD BEEN DISPOSED AND NOT AVAILABLE TO SEND FOR INVESTIGATION.

  Patient problems: Discomfort; Distress; Foreign Body In Patient

  MAUDE report 7820115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152339. One submission often covers many models, so check the product and lot details in each record.

• Z-2078-2021 · May 26, 2021 · Open, Classified
  Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
• Z-0381-2018 · Nov 6, 2017 · Terminated
  Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d
• Z-0382-2018 · Nov 6, 2017 · Terminated
  Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d