McKesson 102-N2558SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30612479178824), received between Dec 29, 2017 and Aug 20, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2021Connection Problem; Fail-Safe Did Not Operate

  WHILE PREFORMING AN INJECTION, I DISCOVERED THE "PREVENT HT SAFETY HYPODERMIC NEEDLE 25 X 5/8" SAFETY COVER DID NOT PROPERLY LATCH ON TO THE NEEDLE SECURING THE NEEDLE WHEN THE IMMUNIZATION WAS DONE. THEN ATTEMPTED TO PUT THE SAFETY SECURELY ON THE NEEDLE BY USING GENTLE PRESSURE AGAINST THE COUNTER AND THE PLASTIC SAFETY SNAPPED EXPOSING THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 12347676 ↗
• MalfunctionMay 25, 2021Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  THE USER FACILITY REPORTED THAT THE HEALTH CARE PROVIDED INCURRED A NEEDLE STICK BECAUSE THE MCKESSON NEEDLE SAFETY DEVICE DID NOT ENGAGE APPROPRIATELY. ADDITIONAL INFORMATION WAS RECEIVED ON 10MAY2021: THE HCP ACTIVATED AGAINST HER THIGH. THIS IS NOT WHERE THE NEEDLE STICK OCCURRED. THE NEEDLE STICK WAS WITH THE NEEDLE USED ON THE PATIENT. THE TESTING PERFORMED ON THE PATIENT WAS FOR (B)(6). THE PATIENT'S CONDITION WAS NOT AFFECTED. THEY FOLLOWED THEIR NEEDLE STICK POLICY AND SENT THE EMPLOYEE FOR TREATMENT, LABS AND COLLECTED FROM THE PATIENT WITH MOTHER'S PERMISSION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11877572 ↗
• InjuryJul 23, 2020Break; Break

  THE USER FACILITY REPORTED THAT WHILE ADMINISTRATING A VACCINE THE MCKESSON BRAND NEEDLE BROKE WHILE INSIDE THE PATIENT. LESS THAN HALF THE NEEDLE BROKE. WHERE THE NEEDLE BROKE IS WHAT BROKE INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 02JULY2020: THE PATIENT WAS EVALUATED AT ER CHOMP, THEN HE WAS REFERRED TO AN ORTHOPEDIC SURGEON. THE SURGEON PERFORMED THE SURGERY AND THE PATIENT REQUIRED GENERAL ANESTHESIA, INTUBATED. FLUOROSCOPIC GUIDANCE WAS USED TO DETECT THE NEEDLE (FOREIGN BODY). AN INLINE INCISION IN THE FACIAL PLANE WAS MADE USING A SKIN KNIFE. A REMOVAL OF FOREIGN BODY IN MUSCLE OR TENDON SHEATH DEEP AND COMPLICATED PERFORMED. INJECTION WAS MMR, WHICH IS ASPIRATED USING A DIFFERENT NEEDLE. DELIVERED INTO THE LEFT THIGH. THERE WAS NO BENDING OF THE NEEDLE NOTED PRIOR TO EVENT AND WAS NOT NOTED BROKEN UNTIL REMOVED FROM THE CHILDS THIGH, POST INJECTION. THE CHILD WAS IMMEDIATELY REFERRED TO THE ER AND SCHEDULED FOR SURGERY THE FOLLOWING MONDAY (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION; HOWEVER, THE DOCTOR HAS NOT BEEN ABLE TO SPEAK WITH THE PARENTS AFTER MULTIPLE ATTEMPTS. THE BROKEN SEGMENT WAS APPROXIMABILITY 6-8 MM.

  Patient problems: No Code Available

  MAUDE report 10316437 ↗
• MalfunctionJan 8, 2020Positioning Failure; Activation Problem; Positioning Failure; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY CAP ON THE NEEDLE DID NOT PROPERLY ENGAGE, LEAVING THE TOP PORTION OF THE NEEDLE EXPOSED RESULTING TO A NEEDLESTICK. THE NURSE WAS STUCK WITH THE NEEDLE DUE TO THIS ISSUE. THE SAFETY CAP ON THE NEEDLE DOES NOT PROPERLY ENGAGE WHICH LEAVES THE TOP PORTION OF THE NEEDLE EXPOSED. THERE WAS NO KNOWN IMPACT ON THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED 13DECEMBER2019: WHEN THE EMPLOYEE TRIED CAPPING THE SAFETY DEVICE, IT FLOPPED BACK. A LOT OF PRESSURE HAD TO BE USED TO CLOSE THEM. THE NEEDLE WAS NOT BENT PRIOR TO ACTIVATION. PROCEDURE WAS COMPLETED SUCCESSFULLY. DIAGNOSTIC TESTING WAS PERFORMED PER FACILITY PROTOCOL.

  Patient problems: Needle Stick/Puncture; No Known Impact Or Consequence To Patient

  MAUDE report 9565379 ↗
• MalfunctionJul 19, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AFTER IMMUNIZATION, THE NURSE WAS DOING THE SAFETY MECHANISM AND STUCK HERSELF. THE NEEDLE WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED JUNE 28, 2019: THE NURSE HAD ACTIVATED THE SAFETY, AND WHEN SHE PICKED UP THE NEEDLE TO DISPOSE SHE WAS STUCK. SHE THEN NOTED THE NEEDLE HAD NOT BEEN ACTIVATED AND WAS BENT. THE NEEDLE WAS NOT BENT PRIOR TO ACTIVATION. THE PATIENT RECEIVED IMMUNIZATION AS INTENDED AND WAS NOT AFFECTED. THE NURSE WAS SENT FOR BLOOD WORK AND WAS CLEARED TO RETURN TO WORK. THE PATIENT BEING TREATED WAS NEGATIVE FOR INFECTIOUS DISEASE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8808456 ↗
• MalfunctionNov 8, 2018Loose or Intermittent Connection; Activation Problem; Loose or Intermittent Connection; Activation Problem

  THE USER FACILITY REPORTED THAT HUB FELL OFF THE NEEDLE RESULTING IN A NEEDLE STICK WHEN BEING DISPOSED. IT WAS REPORTED THAT AFTER GIVING A FLU VACCINE, THE NURSE TAPPED THE ECLIPSE SAFETY ON THE COUNTER. THE PART THAT HOLDS THE NEEDLE WAS DEFECTIVE AND FELL OFF THE NEEDLE. THE NURSE HIT HER LEFT RING FINGER WITH THE NEEDLE WHEN SHE WAS PUTTING THE NEEDLE IN THE SHARPS CONTAINER. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 2, 2018: IT WAS REPORTED THAT THE NURSE WAS FINE. THE FACILITY EXAMINED THE NEEDLE TO DETERMINE WHY THE NEEDLE WAS EXPOSED. THE PATIENT SIGNED A CONSENT FORM TO BE TESTED FOR (B)(6) AND A (B)(6) PANEL. THE NURSE FILLED OUT AN EXPOSURE INCIDENT REPORT AND THE PATIENT AND HER WERE TESTED FOR (B)(6) AND (B)(6). THE RESULTS WERE (B)(6) FOR BOTH THE PATIENT AND THE NURSE. THE SHEATH WAS ACTIVATED BUT DID NOT STAY OVER THE NEEDLE. NO PART OF THE NEEDLE FELL OFF AND THE HUB WAS NOT INVOLVED. INSIDE THE SHEATH WAS A PIECE OF PLASTIC THAT HELD THE NEEDLE IN THE SHEATH. THAT PIECE DID NOT HOLD THE NEEDLE IN THE SHEATH, LEAVING THE NEEDLE TO BE EXPOSED. THE NURSE DID NOT REALIZE THE NEEDLE WAS EXPOSED UNTIL SHE WAS DROPPING IT INTO THE SHARPS CONTAINER. THAT WAS WHEN T

  Patient problems: Needle Stick/Puncture

  MAUDE report 8051662 ↗
• MalfunctionMay 31, 2018Bent; Use of Device Problem; Bent; Use of Device Problem

  THE USER FACILITY REPORTED THAT WHILE THE NURSE WAS GIVING THE PATIENT A SHOT, THE NURSE HIT THE SAFETY ON THE NEEDLE CAUSING IT TO BEND AND STABBED HERSELF IN THE LEFT INDEX FINGER. ADDITIONAL INFORMATION RECEIVED ON 05/04/2018: THE NURSE WENT AND HAD SOME PRECAUTIONARY LAB WORK DONE (DIAGNOSTIC TESTING) AND TO DATE NO ADDITIONAL INTERVENTION HAS BEEN REQUIRED. THE NURSE WHO WAS STUCK WITH THE NEEDLE IS DOING WELL, NOT OTHER ISSUES HAVE BEEN NOTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7558613 ↗
• MalfunctionDec 29, 2017Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THE SAFETY NEEDLES DON'T CLICK INTO SAFETY. IT ACTUALLY BENDS UPWARD INSTEAD OF CLICKING IN TO THE SAFETY MECHANISM. THEY ARE ALSO NOTICING THAT THE NEEDLE BENDS WHEN GIVING AN INJECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153910 ↗