Unifine Pentips AN 3590Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384703590014), received between Aug 25, 2020 and Aug 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  PATIENT'S MOTHER CALLED IN ON (B)(6) 2020 TO REPORT THAT THE NIGHT BEFORE WHEN SHE INJECTED HER SON USING OM 31G 6MM LOT 1909755, THE PEN NEEDLE BROKE OFF INTO THE PATIENT'S LEG. SHE REPORTED THEY TOOK HIM AND THE PEN NEEDLE TO THE EMERGENCY ROOM AND THAT THE HUB WAS LEFT AT HE EMERGENCY DEPARTMENT. SHE REPORTED THAT SHE HAS A ZOOM CONSULT WITH A SURGEON TO DETERMINE IF ANY OTHER ACTIONS ARE NECESSARY. FOLLOW UP WITH THE PATIENT'S MOTHER INDICATED THE DOCTOR SAID THEY WOULD JUST HAVE TO WAIT FOR THE NEEDLE TO COME OUT ON ITS OWN. THE PATIENT'S MOTHER REPORTED SHE WAS INJECTING A GROWTH HORMONE, GENTROPIN. THE IFU FOR GENTROPIN INSTRUCTS THE USERS TO ONLY USE 29G, 30G OR 31G PEN NEEDLES MANUFACTURED BY BECKTON DICKSON. OWEN MUMFORD HAS NOT TESTED GENTROPIN WITH OM PEN NEEDLES AND THERE IS A COMPATIBILITY CHART INCLUDED ON THE PACKAGING WITH DRUGS AND PENS THAT OM HAS TESTED AND CLAIMS COMPATIBILITY WITH. GENTROPIN IS NOT LISTED HERE.

  Patient problems: Anxiety; No Known Impact Or Consequence To Patient

  MAUDE report 10448327 ↗

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