McKesson 102-N251S3Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10612479246390), received between Oct 18, 2023 and Sep 3, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (28 reports).

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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Activation Failure

  Terumo received the following information: It was reported that during the administration of an intramuscular B12 injection, the nurse removed the needle from the patient and attempted to activate the safety mechanism. The safety mechanism failed to engage, resulting in an accidental needlestick injury to the nurse.Additional information was received on 18-Aug-2026: A staff member experienced a needlestick-related bloodborne exposure and sought medical attention. Per facility policy, immediate testing was required following the exposure. The staff member was evaluated at an urgent care facility and followed the medical recommendations provided.Additional information was received on 21-Aug-2026: The thumb was the method of activation used. The staff member was sent to urgent care for precautionary testing; no on-site treatment was necessary. The staff member is doing well with no complications related to the incident, aside from some side effects from the medications she was prescribed as a precautionary measure.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50584163 ↗
• MalfunctionAug 26, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452126 ↗
• MalfunctionMar 30, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PRODUCT HAS BEEN BENDING DURING USE, FAILING TO LOCK PROPERLY WITH THE SAFETY MECHANISM, AND IN SOME CASES, THE NEEDLE REMAINS EXPOSED EVEN AFTER THE SAFETY LOCK HAS BEEN ENGAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAR-2026: HARD-SURFACE ACTIVATION WAS THE METHOD USED. THE HYPODERMIC NEEDLE WAS INSERTED INTO THE INTRAMUSCULAR AND SUBCUTANEOUS TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727389 ↗
• MalfunctionMar 30, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PRODUCT HAS BEEN BENDING DURING USE, FAILING TO LOCK PROPERLY WITH THE SAFETY MECHANISM, AND IN SOME CASES, THE NEEDLE REMAINS EXPOSED EVEN AFTER THE SAFETY LOCK HAS BEEN ENGAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAR-2026: HARD-SURFACE ACTIVATION WAS THE METHOD USED. THE HYPODERMIC NEEDLE WAS INSERTED INTO THE INTRAMUSCULAR AND SUBCUTANEOUS TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726712 ↗
• MalfunctionMar 23, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PRODUCT HAS BEEN BENDING DURING USE, FAILING TO LOCK PROPERLY WITH THE SAFETY MECHANISM, AND IN SOME CASES, THE NEEDLE REMAINS EXPOSED EVEN AFTER THE SAFETY LOCK HAS BEEN ENGAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAR-2026: HARD-SURFACE ACTIVATION WAS THE METHOD USED. THE HYPODERMIC NEEDLE WAS INSERTED INTO THE INTRAMUSCULAR AND SUBCUTANEOUS TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660842 ↗
• MalfunctionMar 23, 2026Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PRODUCT HAS BEEN BENDING DURING USE, FAILING TO LOCK PROPERLY WITH THE SAFETY MECHANISM, AND IN SOME CASES, THE NEEDLE REMAINS EXPOSED EVEN AFTER THE SAFETY LOCK HAS BEEN ENGAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAR-2026: HARD-SURFACE ACTIVATION WAS THE METHOD USED. THE HYPODERMIC NEEDLE WAS INSERTED INTO THE INTRAMUSCULAR AND SUBCUTANEOUS TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660832 ↗
• MalfunctionDec 23, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE CUSTOMER CONFIRMED THAT THE STAFF DOES ENGAGE THE SAFETY MECHANISM CORRECTLY. UPON FURTHER INVESTIGATION, THE SAFETY LOCK IS MISALIGNED ON SOME OF THE NEEDLES, WHICH FORCES THE NEEDLE OUT OR BENDS IT, WHICH HAS CAUSED A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23876210 ↗
• MalfunctionDec 23, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE CUSTOMER CONFIRMED THAT THE STAFF DOES ENGAGE THE SAFETY MECHANISM CORRECTLY. UPON FURTHER INVESTIGATION, THE SAFETY LOCK IS MISALIGNED ON SOME OF THE NEEDLES, WHICH FORCES THE NEEDLE OUT OR BENDS IT, WHICH HAS CAUSED A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23876205 ↗
• MalfunctionNov 21, 2025Activation Failure; Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT CAME IN FOR AN OFFICE VISIT AND TO RECEIVE AN INFLUENZA VACCINE. THE NURSE ADMINISTERED THE VACCINE AND HEARD THE SAFETY ON THE NEEDLE CLICK, HOWEVER IT STILL STUCK THE NURSE'S FINGER. THE NEEDLE SEEMED TO HAVE BEEN A "FAULTY" NEEDLE, OR IT WAS A SAFETY MALFUNCTION ON THE NEEDLE. THE NURSE'S FINGER DID BLEED FOR A LITTLE BIT BUT HAS STOPPED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23617724 ↗
• MalfunctionNov 17, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE BENT OUT OF SAFETY DEVICE RESULTING IN ONE NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23570342 ↗
• MalfunctionNov 12, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AFTER ADMINISTERING A FLU VACCINE USING THE MCKESSON PREVENT SAFETY HYPODERMIC NEEDLE (25G X 1IN) THE EMPLOYEE ENGAGED THE SAFETY COVER. THE NEEDLE BENT BEYOND THE COVER AND WAS EXPOSED CREATING POTENTIAL STICK TO EMPLOYEE; HOWEVER, NO STICK OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2025: THE METHOD OF ACTIVATION WAS AGAINST A HARD SURFACE. THE PATIENT RECEIVED THE VACCINE AS INTENDED WITH NO IMPACT ON THE PATIENT HEALTH. IT WAS A NEAR MISS FOR NEEDLE STICK; HOWEVER, THE DEVICE SHOULD BE CLOSED ON A SURFACE AS TO NOT POKE YOURSELF WHILE CLOSING WITH A FINGER OR THUMB. THE NEEDLE BENT BESIDE THE SHEATH "TOOTH" DESIGNED TO CAPTURE THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534474 ↗
• MalfunctionNov 12, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AFTER ADMINISTERING A FLU VACCINE USING THE MCKESSON PREVENT SAFETY HYPODERMIC NEEDLE (25G X 1IN) THE EMPLOYEE ENGAGED THE SAFETY COVER. THE NEEDLE BENT BEYOND THE COVER AND WAS EXPOSED CREATING POTENTIAL STICK TO EMPLOYEE; HOWEVER, NO STICK OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2025: THE METHOD OF ACTIVATION WAS AGAINST A HARD SURFACE. THE PATIENT RECEIVED THE VACCINE AS INTENDED WITH NO IMPACT ON THE PATIENT HEALTH. IT WAS A NEAR MISS FOR NEEDLE STICK; HOWEVER, THE DEVICE SHOULD BE CLOSED ON A SURFACE AS TO NOT POKE YOURSELF WHILE CLOSING WITH A FINGER OR THUMB. THE NEEDLE BENT BESIDE THE SHEATH "TOOTH" DESIGNED TO CAPTURE THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534335 ↗
• MalfunctionNov 12, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AFTER ADMINISTERING A FLU VACCINE USING THE MCKESSON PREVENT SAFETY HYPODERMIC NEEDLE (25G X 1IN) THE EMPLOYEE ENGAGED THE SAFETY COVER. THE NEEDLE BENT BEYOND THE COVER AND WAS EXPOSED CREATING POTENTIAL STICK TO EMPLOYEE. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2025: THE METHOD OF ACTIVATION WAS AGAINST THE OPERATOR'S THUMB. THE PATIENT RECEIVED THE VACCINE AS INTENDED AND WAS NOT IMPACTED. A NEEDLE STICK OCCURRED FOR THE HCP, WHICH RESULTED IN THEM WASHING AND CLEANING THEIR THUMB AND GOING TO OCCUPATIONAL HEALTH TO GET REQUIRED ANTIBIOTICS. THE NEEDLE HAD BENT THOUGH THE SAFETY SHEATH.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23534334 ↗
• MalfunctionNov 5, 2025Activation Failure; Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE CAP DID NOT CLOSE OVER THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476071 ↗
• MalfunctionNov 4, 2025Activation Failure; Activation Failure

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. A NEEDLESTICK OCCURRED ON (B)(6) 2025. THE PATIENT'S RIGHT FINGER WAS STUCK AFTER ADMINISTERING A FLU VACCINE. THEY NOTED THAT THE PRODUCT'S LOCK DID NOT CLOSE ALL THE WAY, IT WAS STUCK. IT DID NOT LOCK. THE NEEDLESTICK OCCURRED WHEN THEY WERE PUTTING IT INTO THE SHARP'S CONTAINER. EMPLOYEE WAS IN OCCUPATIONAL HEALTH AND BLOOD WAS DRAWN ON THE PATIENT AS A SOURCE PANEL. ADDITIONAL INFORMATION WAS RECEIVED ON 20OCT2025: HARD SURFACE ACTIVATION HAS BEEN USED. THE HYPODERMIC NEEDLE WAS INSERTED IN THE INTRAMUSCULAR. THE NURSE CLEANED THEIR WOUND AND REPORTED TO THE DEPT MANAGER; NO OPERATIONAL IMPACT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23464706 ↗
• MalfunctionOct 22, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE CUSTOMER CLOSED THE SAFETY NEEDLE ON A HARD SURFACE. WHEN TAKING THE SAFETY NEEDLE OFF TO KEEP THE SYRINGE FOR DOCUMENTATION, THE USER WAS STUCK WITH THE NEEDLE IN THE LEFT THUMB THROUGH THE GLOVE. THE BOTTOM OF THE NEEDLE WAS IN THE SAFETY AREA; HOWEVER, THE TOP OF THE NEEDLE WAS STICKING OUT DUE TO BEING BENT IN THE MIDDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEP2025: SINCE IT WAS INDICATED IT HAD BEEN CAPTURED WITHIN THE SAFETY LOCK, THE LOCK FULLY ENGAGED, AND CLICKED, THE NEEDLE ITSELF BENT AND WAS EXPOSED OUT OF THE TIP (NOT THROUGH THE BACK OF THE GUARD). THE METHOD OF ACTIVATION WAS LOCKED ON THE BACK OF THE PHLEBOTOMY CHAIR. THE PATIENT (MA) WENT TO THE EMERGENCY ROOM (ER). THE ER DREW BLOOD, AND SHE FOLLOWED UP WITH OCCUPATIONAL HEALTH YESTERDAY; THEY WILL TREAT PENDING PATIENT LAB RESULTS. THE MA WAS ABLE TO RETURN TO NORMAL DUTIES. THE CONCOMITANT DEVICE USED WITH THE MCKESSON SAFETY HYPODERMIC NEEDLE WAS A MCKESSON LUER LOCK SYRINGE 3ML.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23359641 ↗
• MalfunctionOct 15, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION FROM THE END USER FACILITY'S CLINICAL MANAGER: A NEEDLE STICK INJURY OCCURRED DURING THE ADMINISTRATION OF VITAMIN B12 TO PATIENT IN THE UPPER LEFT DELTOID. AFTER INJECTION, THE MEDICAL ASSISTANT ENGAGED THE SAFETY LOCK ON THE MCKESSON SAFETY HYPODERMIC NEEDLE. WHILE THE LOCK DID ENGAGE AND CLICK, THE NEEDLE BENT. DURING DISPOSAL, THE BENT NEEDLE PIERCED THE MEDICAL ASSISTANT'S LEFT THUMB, BREAKING THROUGH HER GLOVES AND SKIN. THE MEDICAL ASSISTANT HAS LONG-STANDING TRAINING AND EXPERIENCE IN HANDLING SHARPS DEVICES. SHE WAS SENT TO THE EMERGENCY ROOM AND WILL FOLLOW UP WITH OCCUPATIONAL HEALTH. ADDITIONAL INFORMATION RECEIVED ON 18 SEP 2025 INDICATED THAT THE LOCK WAS FULLY ENGAGED AND CLICKED; HOWEVER, THE NEEDLE BENT AND REMAINED EXPOSED AT THE TIP (NOT THROUGH THE BACK OF THE GUARD). THE METHOD OF ACTIVATION WAS AGAINST A HARD SURFACE THE BACK OF A PHLEBOTOMY CHAIR. THE MEDICAL ASSISTANT WAS EVALUATED IN THE EMERGENCY ROOM, WHERE BLOOD WAS DRAWN, AND SHE FOLLOWED UP WITH OCCUPATIONAL HEALTH THE FOLLOWING DAY. TREATMENT IS PENDING PATIENT LAB RESULTS. THE MEDICAL ASSISTANT WAS ABLE TO RETURN TO NORMAL DUTIES. THE PATIENT WAS NOT

  Patient problems: Needle Stick/Puncture

  MAUDE report 23306964 ↗
• MalfunctionSep 18, 2025Malposition of Device; Malposition of Device

  TERUMO MEDICAL RECEIVED A REPORT STATING THAT AFTER ADMINISTERING THE GARDASIL VACCINE TO A PATIENT, A STAFF MEMBER ATTEMPTED TO CLOSE THE SAFETY NEEDLE ON A HARD SURFACE. WHILE REMOVING THE SAFETY NEEDLE TO RETAIN THE SYRINGE FOR DOCUMENTATION, THE STAFF MEMBER WAS ACCIDENTALLY STUCK IN THE LEFT THUMB THROUGH A GLOVE. THE BOTTOM OF THE NEEDLE WAS SECURED WITHIN THE SAFETY MECHANISM; HOWEVER, THE TOP PORTION WAS PROTRUDING DUE TO A BEND IN THE MIDDLE OF THE NEEDLE. THE STAFF MEMBER WAS EVALUATED IN THE EMERGENCY ROOM AND FOLLOWED UP WITH OCCUPATIONAL HEALTH THE NEXT DAY. THE PATIENT WHO RECEIVED THE VACCINE WAS NOT INJURED AND WAS LATER BROUGHT BACK TO THE HOSPITAL FOR BLOODWORK. ADDITIONAL INFORMATION RECEIVED ON 26 AUG 2025: THE STAFF MEMBER RETURNED TO NORMAL DUTIES THE FOLLOWING DAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23082247 ↗
• MalfunctionJul 18, 2025Malposition of Device; Malposition of Device

  A USER FACILITY REPORTED A SAFETY MALFUNCTION INVOLVING A HYPODERMIC NEEDLE. AFTER ADMINISTERING A VACCINE, A CLINICAL STAFF MEMBER ATTEMPTED TO ENGAGE THE NEEDLE'S SAFETY MECHANISM; HOWEVER, THE NEEDLE DID NOT FULLY ENGAGE AND INSTEAD BENT OUTWARD, PROTRUDING OUTSIDE OF THE SAFETY DEVICE RATHER THAN SNAPPING SECURELY INTO PLACE. AS THE STAFF MEMBER ATTEMPTED TO DISPOSE OF THE NEEDLE INTO A SHARPS CONTAINER, THEY SUSTAINED A NEEDLESTICK INJURY FROM THE CONTAMINATED NEEDLE, WHICH WAS EXPOSED ABOVE THE SAFETY MECHANISM. THE INCIDENT WAS ATTRIBUTED TO A DEFECTIVE SAFETY FEATURE ON THE HYPODERMIC NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 20 JUN 2025: THE CLINICAL STAFF MEMBER IMMEDIATELY CEASED ALL ACTIVITIES, WASHED HER HANDS WITH SOAP AND WATER, CONTACTED THE OCCUPATIONAL HEALTH DEPARTMENT, COMPLETED INCIDENT-RELATED DOCUMENTATION, AND UNDERWENT LABORATORY TESTING. THE CLINICAL STAFF MEMBER'S CONDITION IS CURRENTLY STABLE, THOUGH SHE IS EXPERIENCING STRESS RELATED TO THE INCIDENT. THE CLINICAL STAFF MEMBER USED HER THUMB TO ACTIVATE THE SAFETY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22542023 ↗
• MalfunctionJul 10, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT AN EMPLOYEE STATED SHE HAD USED HER THUMB TO ACTIVATE THE SAFETY DEVICE, AND THE NEEDLE BENT DURING THE ATTEMPT. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 12 JUN 2025: THE STAFF MEMBER ACTIVATED THE NEEDLE USING HER THUMB, AND NO NEEDLESTICK INJURY OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED ON 13 JUN 2025: THE NEEDLE BENDING OCCURRED AFTER THE MEDICATION WAS ADMINISTERED, THE NEEDLE SUCCESSFULLY DELIVERED THE MEDICATION, BUT THE SAFETY DEVICE WAS NOT SUCCESSFULLY ACTIVATED, AND THE NEEDLE WAS NOT CORRECTLY SEATED OR SAFELY SECURED BY THE DEVICE. THE INJECTION WAS INTRAMUSCULAR, BUT THE EXACT SITE OF ADMINISTRATION (E.G., DELTOID) IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470398 ↗
• MalfunctionApr 23, 2025Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT DURING USE, THE NEEDLES WOULD BEND. ADDITIONAL INFORMATION RECEIVED ON 27 MAR 2025: THE NEEDLES WERE NOT BEING USED DUE TO THE BENDING ISSUE DURING PEDIATRIC INJECTIONS WITH FREQUENTLY ACTIVE PATIENTS.. THE PRODUCT WAS PUT ASIDE TO PREVENT FURTHER INCIDENTS. NO NEEDLE STICKS OCCURRED IN ANY OF THE EVENTS, AND NO PATIENT OR HEALTH CARE PROVIDER (HCP) INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894814 ↗
• MalfunctionApr 23, 2025Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT DURING USE, THE NEEDLES WOULD BEND. IN ONE CASE, THE HEALTH CARE PROVIDER (HCP) WITNESSED THE NEEDLE BENDING TO THE SIDE AND THROUGH THE PROTECTIVE SHEATH WHEN ACTIVATED AGAINST A HARD SURFACE. NO NEEDLE STICK OCCURRED, AND NO PATIENT OR HCP INJURIES WERE REPORTED. THE NEEDLE WAS USED FOR PEDIATRIC PATIENT VACCINES WITH PREFILLED VIALS OR SYRINGES THAT CAME WITH THE VACCINES, NOT TERUMO SYRINGES. ADDITIONAL INFORMATION RECEIVED ON 27 MAR 2025: THE NEEDLES WERE NOT BEING USED DUE TO THE BENDING ISSUE DURING PEDIATRIC INJECTIONS WITH FREQUENTLY ACTIVE PATIENTS. THE PRODUCT WAS PUT ASIDE TO PREVENT FURTHER INCIDENTS. NO NEEDLE STICKS OCCURRED IN ANY OF THE EVENTS, AND NO PATIENT OR HEALTH CARE PROVIDER (HCP) INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894811 ↗
• MalfunctionApr 17, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE RETRACTION MECHANISM OF THE DEVICE IS JAMMING, WHICH RESULTED IN ONE NEEDLESTICK. THE CUSTOMER DISCARDED THE REMAINDER OF THE BOX, SO NO SAMPLE IS AVAILABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21856277 ↗
• MalfunctionApr 17, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE RETRACTION MECHANISM OF THE DEVICE IS JAMMING, WHICH RESULTED IN ONE NEEDLESTICK. THE CUSTOMER DISCARDED THE REMAINDER OF THE BOX, SO NO SAMPLE IS AVAILABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21854939 ↗
• MalfunctionMar 26, 2025Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT THE NEEDLE BENT WHILE THEY WERE TRYING TO ENGAGE THE SAFETY MECHANISM. ADDITIONAL INFORMATION WAS RECEIVED ON 26 FEBRUARY 2025: THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE STAFF MEMBER WAS ACTIVATING THE NEEDLE AGAINST A HARD SURFACE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS A NEEDLE STICK INCIDENT. THE PATIENT IS STABLE. THE NEEDLE WAS NOT CONFIRMED TO BE SUCCESSFULLY ACTIVATED WITHIN THE SAFETY SHEATH. POST PATIENT TREATMENT, THE NEEDLE BENT WHILE ACTIVATING THE SAFETY SHEATH. THE HYPODERMIC NEEDLE WAS INSERTED INTRAMUSCULARLY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21694786 ↗