Kroger AN 3540KRORecalls & reported problems
Kroger CO., The · Kroger Pentips, 4mm x 32G, 100 ct · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00041260007781), received between Jun 29, 2022 and Sep 11, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Separation Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Separation Problem3
- Detachment of Device or Device Component2
- Activation, Positioning or Separation Problem1
Patient problems
- Foreign Body In Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Separation Problem; Separation Problem
NEEDLE BROKE OFF IN ABDOMEN. PATIENT WENT TO URGENT CARE AND THEY SENT HIM TO THE ER WITH INSTRUCTIONS TO GET A SONOGRAM. THE ER DID NOT DO A SONOGRAM BUT THEY DID AN X-RAY AND SAID THAT DIDN'T SS THE NEEDLE. PATIENT SAYS HE CAN FEEL THE NEEDLE IN HIS ABDOMEN AND IS WORRIED IT IS GOING TO GET INFECTED OR CAUSE OTHER PAIN AND DAMAGE TO HIS STOMACH AREA. CUSTOMER SERVICE INSTRUCTED PATIENT TO FOLLOW THE ADVICE OF HIS PHYSICIAN.
Patient problems: Foreign Body In Patient
MAUDE report 20191488 ↗InjurySep 11, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NEEDLE BROKE OFF IN ABDOMEN. PATIENT WENT TO URGENT CARE AND THEY SENT HIM TO THE ER WITH INSTRUCTIONS TO GET A SONOGRAM. THE ER DID NOT DO A SONOGRAM BUT THEY DID AN X-RAY AND SAID THEY DIDN'T SS THE NEEDLE. PATIENT SAYS HE CAN FEEL THE NEEDLE IN HIS ABDOMEN AND IS WORRIED IT IS GOING TO GET INFECTED OR CAUSE OTHER PAIN AND DAMAGE TO HIS STOMACH AREA. CUSTOMER SERVICE INSTRUCTED PATIENT TO FOLLOW THE ADVICE OF HIS PHYSICIAN.
Patient problems: Foreign Body In Patient
MAUDE report 20191471 ↗InjuryMar 10, 2023Separation Problem; Separation Problem
CUSTOOMER STATED TO US OIFFICE THAT THE NEEDLE BROKE OFF IN HER STOMACH DURING HER MORNING INJECTION. SHE FURTHER STATED SHE WAS ABLE TO PULL THE NEEDLE OUT OF HER STOMACH, BUT IT WAS PAINFUL. SHE DIDN'T SAVE THE BROKEN PIECE FROM HER STOMACH, BUT DID SAVE TEH PEN NEEDLE HUB. SHE HAS NOT GONE TO THE DOCTOR AND REPORTED THAT SHE WATCHED THE SITE AND DID NOT GO TO THE ER.
Patient problems: Foreign Body In Patient
MAUDE report 16526435 ↗InjuryMar 10, 2023Separation Problem; Separation Problem
CUSTOMER STATED THE NEEDLE BROKE OFF IN HER STOMACH DURING HER MORNING INJECTION. SHE FURTHER STATED SHE WAS ABLE TO PULL THE NEEDLE OUT OF HER STOMACH, BUT IT WAS PAINFUL. SHE DIDN'T SAVE THE BROKEN PIECE FROM HER STOMACH, BUT DID SAVE THE PEN NEEDLE HUB. SHE HAS NOT GONE TO THE DOCTOR AND REPORTED THAT SHE WATCHED THE SITE AND DID NOT GO TO THE EMERGENCY ROOM.
Patient problems: Foreign Body In Patient
MAUDE report 16526432 ↗InjuryJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT CALLED TO ADVISE US THAT A NEEDLE BROKE OFF IN HIS BUTT WHILE GIVING AN INJECTION. CUSTOMER STATED THAT HE DID GET THE NEEDLE OUT OF HIS SKIN, BUT HE DID NOT SAVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14860613 ↗InjuryJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
US OFFICE RECEIVED COMPLAINT FROM PATIENT STATING A NEEDLE BROKE OFF IN HIS BUTT WHILE GIVING AN INJECTION. CUSTOMER STATED THAT HE DID GET THE NEEDLE OUT OF HIS SKIN, BUT HE DID NOT SAVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14860549 ↗
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-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
- 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
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.