EasyPoint® 82091Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613703820907), received between Jul 17, 2018 and May 1, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 5, 2024Open, Classified

   The needle cannula of a retractable needle may detach from the needle holder in the patient.

   Z-1293-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024

  REGISTERED NURSE (RN) ADMINISTERED SC HEPARIN AS ORDERED. WHEN SHE RETRACTED NEEDLE AFTER ADMINISTRATION, NEEDLE REMAINED IN PATIENT'S ABDOMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220467 ↗
• MalfunctionMar 18, 2024

  WHILE DRAWING UP HEPARIN THE NEEDLE CAME OUT OF THE RETRACTABLE HUB. THE NEEDLE WAS STUCK IN THE VIAL.

  Patient problems: Insufficient Information

  MAUDE report 18920631 ↗
• MalfunctionMar 18, 2024

  RN PULLED AN EASYPOINT 25G NEEDLE OUT OF THE SUPPLY CART AND NOTICED THE ORIGINAL NEEDLE INTACT INSIDE THE SAFETY CAP, AS WELL AS AN EXTRA LOOSE NEEDLE INSIDE OF THE PACKAGING.

  Patient problems: Insufficient Information

  MAUDE report 18920629 ↗
• MalfunctionJan 24, 2024

  RN WENT TO ENGAGE SAFETY MECHANISM OF INTRAMUSCULAR NEEDLE AND THE ENTIRE INTRAMUSCULAR NEEDLE TOP FELL APART INTO MANY PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571315 ↗
• InjuryJan 18, 2024Material Separation; Material Separation

  INITIAL REPORT OF NEEDLE SEPARATION IN PATIENT WAS SUBMITTED BY VACCINE MANAGER OF USER FACILITY ON NOVEMBER 9, 2023. THE INITIAL INFORMATION WAS REPORTED AS FOLLOWS: NURSE GAVE FLUE VACCINE IN CHILD'S THIGH. WHEN SHE WENT TO RETRACT THE NEEDLE IT WENT INSIDE OF THE PATIENT'S THIGH. THE PATIENT WENT TO HOSPITAL AND HAD TO HAVE IT REMOVED VACCINE MANAGER REPORTED THAT FACILITY DID NOT RETAIN INVOLVED PRODUCT BUT HAD ASSOCIATED PRODUCT. SHIPPING CONTAINERS WERE SENT FOR RETURN OF ASSOCIATED PRODUCT AND RECEIPT WAS CONFIRMED ON NOVEMBER 17, 2023. NOVEMBER 17, 2023 REPORTING VACCINE MANAGER TO FOLLOW UP REGARDING TREATMENT AND OUTCOME OF PATIENT INVOLVED IN THE INCIDENT. ASSOCIATED PRODUCT WAS RECEIVED AND TESTING WAS COMPLETED ON DECEMBER 28, 2023. ALL SAMPLES RETURNED WERE TESTED AND WERE WITHIN SPECIFICATION. VACCINE MANAGER PROVIDED FOLLOW UP INFORMATION ON NOVEMBER 29, 2023 STATING THAT THE PATIENT'S MOTHER RETURNED TO THE HOSPITAL AND THE NEEDLE WAS SURGICALLY REMOVED BY THE HOSPITAL. THE SAME DAY VACCINE MANAGER PROVIDED AN IMAGE OF A DETACHED NEEDLE, AN XRAY OF NEEDLE IN PATIENT'S THIGH AND AN XRAY THAT SHOWS NO NEEDLE. ON DECEMBER 19, 2023 THE VACCINE MANAGER REPORTED THAT NO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18539548 ↗
• MalfunctionApr 7, 2023Break

  WHILE ADMINISTERING SUBCUTANEOUS HEPARIN, REGISTERED NURSE ATTEMPTED TO RETRACT THE NEEDLE. THE SAFETY NEEDLE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 16701379 ↗
• MalfunctionJul 22, 2022Retraction Problem

  RETRACTING NEEDLE DID NOT OPERATE CORRECTLY CAUSING RN TO STICK HERSELF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15084187 ↗
• MalfunctionNov 13, 2019Break; Unintended Ejection

  AFTER ADMINISTERING FLU VACCINE, NEEDLE SAFETY DEVICE ACTIVATED BY PRESSING ORANGE BUTTON, NEEDLE SHOT INTO AIR AND BOTH HUB AND NEEDLE MECHANISM BROKE INTO PIECES. PIECES WERE ABLE TO BE RECOVERED AND NO ONE WAS HURT OR HIT BY ANY OF THE PIECES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314669 ↗
• MalfunctionJun 18, 2019Output Problem; Fail-Safe Did Not Operate

  PATIENT WAS GIVEN THE SQ HEPARIN INJECTION AND SAFETY NEEDLE WOULD NOT FUNCTION. NURSE TRIED TO ACTIVE THE SAFETY MECHANISM 3 TIMES WITHOUT SUCCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707109 ↗
• MalfunctionJun 4, 2019Retraction Problem

  RN WAS GIVING THE PATIENT HIS EVENING HEPARIN INJECTION SQ IN THE LOWER LEFT QUADRANT OF THE ABDOMEN. ONCE THE HEPARIN WAS INSTILLED, RN WENT TO RETRACT THE NEEDLE UTILIZING THE BUTTON ON THE EASYPOINT 25G X 5/8" NEEDLE AND THE BUTTON DID NOT RETRACT. THE NEEDLE WAS RETRACTED MANUALLY FROM THE PATIENT'S INJECTION SITE. AFTER A SECOND ATTEMPT TO CLICK THE BUTTON ON THE EASYPOINT NEEDLE, THE SPRING FINALLY RELEASED AND THE NEEDLE RETRACTED BACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666563 ↗
• MalfunctionMar 12, 2019Retraction Problem

  RN WAS ADMINISTERING SC HEPARIN INJECTION TO PATIENT AND SAFETY NEEDLE DID NOT RETRACT. RN NOTICED ON REMOVING THE HEPARIN SYRINGE THAT NEEDLE WAS NOT RETRACTED. NEITHER RN NOR PATIENT WERE STUCK BY NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412081 ↗
• MalfunctionMar 4, 2019Retraction Problem

  RETRACTABLE NEEDLE DID NOT RETRACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8385885 ↗
• MalfunctionJan 30, 2019Detachment of Device or Device Component; Mechanical Jam

  THIS REGISTERED NURSE WENT TO ADMINISTER HEPARIN WITH RETRACTABLE NEEDLE ATTACHMENT. WHEN ATTEMPTING TO USE SAFETY LOCK, LOCK FELT JAMMED AND UNABLE TO USE APPROPRIATELY. TOOK NEEDLE OUT OF PATIENT'S ABDOMEN AND ATTEMPT TO SAFETY LOCK AWAY FROM PATIENT. AT THAT POINT NEEDLE AND SPRING FROM SAFETY LOCK FLEW ACROSS ROOM. ALL PARTS FOUND AND COLLECTED AND PRESENTED TO MANAGER IN STERILE CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288284 ↗
• MalfunctionOct 22, 2018Retraction Problem

  THIS RN ADMINISTERED SUBQ HEPARIN UTILIZING THE "EASY POINT NEEDLE 25GX5/8"" RETRACTABLE. NEEDLE WAS INJECTED AND THE BUTTON WAS PRESSED WHILE NEEDLE WAS STILL INSIDE PATIENT TO RETRACT THE NEEDLE, BUT WHEN THIS RN MOVED HER HAND THE NEEDLE WAS STILL EXPOSED EVEN THOUGH IT "RETRACTED" WHEN THE ORANGE BUTTON WAS PRESSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989869 ↗
• MalfunctionJul 17, 2018Retraction Problem

  RN GAVE PATIENT A HEPARIN SHOT USING EASY POINT NEEDLE 25G X 5/8" AND IT DID NOT RETRACT AFTER USE WHEN DEPRESSED. IT DID RETRACT AS RN PLACED IT IN THE SHARPS CONTAINER AND NEEDLE TOUCHED EDGE OF CONTAINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7693747 ↗