Pentips AN 3450Recalls & reported problems
Owen Mumford USA Incorporated · Pentips pen needles - 5mm x 31G · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384703450011), received between Jul 27, 2023 and Jul 27, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Separation Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Separation Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2023Separation Problem; Separation Problem
CUSTOMER'S BOYFRIEND CALLED TO REPORT THE DAY AFTER. HE COMMUNICATED THAT HIS GIRLFRIEND GAVE HERSELF AN INJECTION AND WHEN SHE WENT TO PULL IT OUT, THE NEEDLE BROKE OFF IN HER SKIN. SHE WENT TO THE ER AND THEY WERE ABLE TO REMOVE IT. SHE DOES NOT HAVE THE PEN NEEDLE HUB OR THE PEN NEEDLE THEY REMOVED TO SEND BACK.
Patient problems: Foreign Body In Patient
MAUDE report 17406457 ↗InjuryJul 27, 2023Separation Problem; Separation Problem
CUSTOMER'S BOYFRIEND CALLED IN TO OM INC TO REPORT THE DAY AFTER SHE GAVE HERSELF AN INJECTION. HE COMMUNICATED THAT WHEN SHE WENT TO PULL IT OUT THE NEEDLE BROKE OFF IN HER SKIN. SHE WENT TO THE ER AND THEY WERE ABLE TO REMOVE IT. SHE DOES NOT HAVE THE PEN NEEDLE HUB OR THE PEN NEEDLE THEY REMOVED TO SEND BACK.
Patient problems: Foreign Body In Patient
MAUDE report 17406370 ↗
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, ClassifiedUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Z-0382-2018 · Nov 6, 2017 · TerminatedUnifine 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
- Z-0381-2018 · Nov 6, 2017 · TerminatedUnifine 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
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.