McKesson 102-N2558S3Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479246406), received between Oct 16, 2024 and Mar 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 24726834 ↗
• 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 24726776 ↗
• MalfunctionFeb 11, 2026Malposition of Device

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SLIT THAT THE NEEDLE GOES INTO APPEARED TO BE ATTACHED ALL THE WAY ACROSS AND PUSHED THE NEEDLE OUT INSTEAD OF ALLOWING IT TO GO INTO THE SAFETY CAP. ADDITIONAL INFORMATION WAS RECEIVED ON 15JAN2026: THERE WAS AN EMPLOYEE NEEDLE STICK/EXPOSURE WHICH REQUIRED THE EXPOSURE PROTOCOL/PROCEDURES POST STICK. ADDITIONAL INFORMATION WAS RECEIVED ON 28JAN2026: PEDIATRIC VACCINES HAD TAKEN PLACE PRIOR TO ATTEMPTED ACTIVATION. THE PATIENT WAS NOT AFFECTED IN ANY WAY. THE PROCEDURES (INJECTIONS) WERE COMPLETED. THE STAFF REPORTED THAT THEY WERE ATTEMPTING TO ACTIVATE THE SAFETY ON A HARD SURFACE. THE NURSE WAS STUCK IN THEIR LEFT-HAND INDEX FINGER WHILE ATTEMPTING TO ENGAGE THE SAFETY. THE EMPLOYEE WAS SEEN AT THE WORKPLACE WELLNESS AT THE LOCAL HOSPITAL AND BBP LABS WERE DRAWN PER THE BBP POLICY. SOURCE LABS WERE NOT OBTAINED AS THEY WERE LOW RISK. THE NEEDLE STICK DID NOT CAUSE BLOOD LOSS, OR REQUIRE ADDITIONAL TREATMENT. (ASIDE FROM SIMPLE FIRST AID). THE STAFF MEMBER WAS STABLE AND RETURNED TO NORMAL DUTIES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24313519 ↗
• MalfunctionFeb 11, 2026Malposition of Device

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SLIT THAT THE NEEDLE GOES INTO APPEARED TO BE ATTACHED ALL THE WAY ACROSS AND PUSHED THE NEEDLE OUT INSTEAD OF ALLOWING IT TO GO INTO THE SAFETY CAP. ADDITIONAL INFORMATION WAS RECEIVED ON 15JAN2026: THERE WAS AN EMPLOYEE NEEDLE STICK/EXPOSURE WHICH REQUIRED THE EXPOSURE PROTOCOL/PROCEDURES POST STICK. ADDITIONAL INFORMATION WAS RECEIVED ON 28JAN2026: PEDIATRIC VACCINES HAD TAKEN PLACE PRIOR TO ATTEMPTED ACTIVATION. THE PATIENT WAS NOT AFFECTED IN ANY WAY. THE PROCEDURES (INJECTIONS) WERE COMPLETED. THE STAFF REPORTED THAT THEY WERE ATTEMPTING TO ACTIVATE THE SAFETY ON A HARD SURFACE. THE NURSE WAS STUCK IN THEIR LEFT-HAND INDEX FINGER WHILE ATTEMPTING TO ENGAGE THE SAFETY. THE EMPLOYEE WAS SEEN AT THE WORKPLACE WELLNESS AT THE LOCAL HOSPITAL AND BBP LABS WERE DRAWN PER THE BBP POLICY. SOURCE LABS WERE NOT OBTAINED AS THEY WERE LOW RISK. THE NEEDLE STICK DID NOT CAUSE BLOOD LOSS, OR REQUIRE ADDITIONAL TREATMENT. (ASIDE FROM SIMPLE FIRST AID). THE STAFF MEMBER WAS STABLE AND RETURNED TO NORMAL DUTIES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24313518 ↗
• MalfunctionJan 16, 2025Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5162171. THE EVENT DESCRIPTION STATES THAT: DURING A CHILD IMMUNIZATION CLINIC, TWO NURSES REPORTED THAT THE NEEDLES WERE BREAKING WHEN TRYING TO DRAW UP THE VACCINE FROM THE VIAL. ADDITIONALLY, CHILDREN REPORTED DISCOMFORT WITH VACCINE ADMINISTRATIONS THAT WOULDN'T NORMALLY CAUSE DISCOMFORT. THE NURSES ALSO DESCRIBED THAT THE NEEDLES FELT DULL. ADDITIONAL INFORMATION WAS RECEIVED ON 17 DEC 2024: DURING PREPARATION FOR VACCINE DELIVERY, PRIOR TO PATIENT INTERACTION, SEVERAL ISSUES WITH THE NEEDLES WERE REPORTED. IN ONE INSTANCE, THE NEEDLE BROKE OFF AT THE HUB, WHILE IN OTHER CASES, THE SHAFT OF THE NEEDLE BROKE OFF. ADDITIONALLY, A SECOND NURSE REPORTED THAT THE NEEDLE BENT WHILE DRAWING UP THE VACCINE, NECESSITATING ITS REPLACEMENT BEFORE PATIENT INJECTION. TO RESOLVE THESE ISSUES AND CONTINUE WITH VACCINE DELIVERY AS INTENDED, A NEW NEEDLE HAD TO BE USED TO DRAW UP THE VACCINE. IN AT LEAST ONE CASE, THE VACCINE HAD TO BE DISCARDED, AND A NEW DOSE WAS DRAWN UP. THIS RESULTED IN A LONGER WAIT TIME FOR THE PATIENT, AS THE VACCINE TOOK LONGER TO PREPARE ACCURATELY FOR ADMINISTRATION. ADDITIONAL INFORMATION WAS RECEIVED ON 30 DEC 202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173360 ↗
• MalfunctionOct 16, 2024Malposition of Device; Malposition of Device

  THE USER FACILITY THAT AN EMPLOYEE WAS STUCK WITH THE INVOLVED NEEDLE. THE EMPLOYEE HAD JUST FINISHED GIVING A PATIENT A FLU SHOT. WHEN THE EMPLOYEE ENGAGED THE SAFETY, THE NEEDLE BENT INSTEAD OF REMAINING STRAIGHT AND PRICKED HER FINGER. ADDITIONAL INFORMATION WAS RECEIVED ON 18 SEPT 2024: THE NEEDLE WAS NOT CONFIRMED TO BE SUCCESSFULLY ACTIVATED WITHIN THE SAFETY SHEATH POST-PATIENT INJECTION. THE HEALTHCARE PROFESSIONAL (HCP) WHO INCURRED THE NEEDLESTICK USED THEIR FINGER FOR ACTIVATION. THE NEEDLESTICK DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION BEYOND SIMPLE FIRST AID, AND THE HCP WAS ABLE TO CONTINUE NORMAL DUTIES AFTERWARD. THE HCP NOW CONSIDERED THE PATIENT DUE TO THE NEEDLESTICK. THE PATIENT AGREED TO HAVE THEIR BLOOD DRAWN FOR SOURCE PERSON TESTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20465903 ↗