SOL-CARE™ Safety Needle SN2510Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00818392010497), received between May 16, 2025 and Aug 22, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT WHEN ADMINISTERING THE MEN-C-C VACCINE TO A 2-MONTH-OLD INFANT, THE VACCINE CONTENTS LEAKED OUT FROM BASE OF THE 1-INCH NEEDLE (WHERE CONNECTED TO THE SYRINGE/ VACCINE) UPON DEPRESSING THE PLUNGER/ ADMINISTERING.NO VACCINE WAS ADMINISTERED INTO THE MUSCLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870263 ↗
• MalfunctionJul 29, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THE SAFETY CAP DID NOT SECURE PROPERLY WHEN CLICKED AND RESULTED IN NURSE NEEDLESTICK INJURY. ORANGE SAFETY CAP IS VERY FLIMSY, AND PLASTIC DOES NOT LATCH SECURELY OR RELIABLY. DESIGN OF ORANGE SAFETY CAP IS THIN AND SMOOTH AND NOT SAFE TO CLOSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22641358 ↗
• MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THE VACCINE SPRAYED OUT FROM BETWEEN THE NEEDLE AND SYRINGE AND DID NOT GET INJECTED INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574110 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THE NEEDLES ARE DIFFICULT TO USE, AND UNCAPPING/RECAPPING IS LEADING TO NEEDLE STICK INJURIES AMONG STAFF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22306645 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THE MULTIPLE ISSUES WITH SAFETY. WE ORDER THE OTHER ONES, AND THEY KEEP SENDING THESE. THEY ARE NOT SAFE. A NEEDLESTICK INJURY OCCURRED TODAY BUT MANY OTHER TIMES THESE HAVE BEEN A SAFETY RISK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22305999 ↗
• MalfunctionJun 17, 2025Decoupling; Decoupling

  CUSTOMER REPORTED THAT THE SYRINGE DOES NOT ATTACH TO NEEDLE SECURELY. THE SYRINGE POPS OFF EASILY CAUSING INJURIES. THE NEEDLE BENDS EASILY WHICH CAN CAUSE INJURY TO THE PATIENT AND IMMUNIZER. NO ADVERSE EVENT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22226585 ↗
• MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): 2024-07-05 INCIDENT DETAILS: CLIENT SEEN IN WELL CHILD CLINIC. I ATTACHED SYRINGE (REF SN2510, LOT 07108039) TO TDAP-IPV. NO PROBLEMS NOTED WITH NEEDLE AT THAT TIME. I IMMUNIZED THE CLIENT IN THE LEFT ARM. NOTHING ABNORMAL HAPPENED DURING IMMUNIZATION. I DID NOT HIT THE BONE. THERE WAS NO PROBLEMS INJECTING. NO LEAKING AROUND NEEDLE. BUT WHEN I PULLED OUT THE NEEDLE FROM CLIENT'S ARM, IT WAS BENT WHERE THE METAL NEEDLE ATTACHES TO THE PLASTIC HUB. IMPACT OF INCIDENT: NO HARM TO CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035706 ↗
• MalfunctionMay 16, 2025Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent

  CUSTOMER REPORTED: NEEDLES HAVE SEVERAL ISSUES. NEEDLES ARE FLIMSY AND BEND EASILY. SAFETY CAP DOESNT SNAP IN PLACE CLEANLY AND SOMETIMES DOESNT OFFER PROTECTION AND NEEDLE HUB DOESNT HOLD TO SYRINGE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035701 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ATTEMPTING TO DISPEL AIR FROM SYRINGE. VACCINE SPRAYED FROM CONNECTION OF NEEDLE TO VACCINE SYRINGE. 4 DOSES OF HEXA, 2 DOSES OF BOOSTRIX POLIO AND 1 DOSE OF MEN C WASTED. SUSPECT BLOCKED NEEDLES. IMPACT OF INCIDENT: NO PATIENT AFFECTED LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035670 ↗
• MalfunctionMay 16, 2025Suction Failure; Suction Failure

  CUSTOMER REPORTED THE NEEDLE WAS BLOCKED, I CHECKED OTHER NEEDLES FORM THE PACKAGE AND FOUND 2 OTHER NEEDLES BLOCKED WHERE IT WAS DIFFICULT TO PUT AIR THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035663 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024 TYPE OF INCIDENT/PROBLEM: DEFECT (DETECTED BEFORE USE) INCIDENT DETAILS: WE HAVE HAD A FEW INCIDENTS WITH THE NEEDLE WHEN ATTACHED TO A VACCINE, THE VACCINE LEAKS AT THE JUNCTION OF ATTACHMENT NEEDLE AND VACCINE. VACCINE GETS WASTED. QUERY DEFECT WITH NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035624 ↗
• MalfunctionMay 16, 2025Decoupling; Decoupling

  "CUSTOMER REPORTED: NEEDLE DISCONNECTED FROM LUER LOCK SYRINGE WHEN PHN ACTIVATED THE SAFETY DEVICE. NEEDLE THEN FLEW ACROSS THE ROOM BUT DIDN'T HIT ANYONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035579 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  "CUSTOMER REPORTED: WHILE NURSE WAS ADMINISTERING DTAP-IPV VACCINE, VACCINE SQUIRTED OUT OF NEEDLE HUB RATHER THAN GOING INTO THE CLIENT'S ARM. NEEDLE AND SYRINGE REMAINED CONNECTED, BUT VACCINE SQUIRTED OUT AROUND THE HUB. VACCINE NEEDED TO BE READMINISTERED TO CLIENT ON OPPOSITE ARM. NEEDLE USED WITH PRE-FILLED BOOSTRIX VACCINE SYRINGE, LEUR SLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035562 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  "CUSTOMER REPORTED: CONCERN IS ABOUT THE USE AND SAFETY OF THE SOL-CARE SAFETY NEEDLE. I PLACED A SOL-CARE 25G X 1" NEEDLE ON THE MENCON C (NEISVAC-C) VACCINE SYRINGE. THIS SYRINGE IS A SLIP TIP TYPE. AS I TRIED TO LOOSEN THE NEEDLE CAP OFF PRIOR TO ADMINISTRATION THE COMPLETE NEEDLE UNIT PULLED AWAY FROM THE SYRINGE AND VACCINE LEAKED ON MY DESK DRAPE."

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 22035560 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  "CUSTOMER REPORTED: SOL CARE ONE INCH NEEDLE CAME APART FROM PRELOADED SYRINGE OF BOOSTRIX-POLIO VACCINE. VACCINE SPRAYED AND UNABLE TO DETERMINE HOW MUCH CLIENT RECEIVED. VACCINE REPEATED IN OTHER ARM.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 22035558 ↗
• MalfunctionMay 16, 2025Break; Break

  "CUSTOMER REPORTED: SOL-CARE SAFETY NEEDLE LDS REF SN2510 25 GAUGE 1-INCH FROM SOL-MILENNIUM MEDICAL INC. USED TO RE-CONSTITUTE INFANRIX-HEXA (DTAP-IPV-HIB-HB) PRODUCT PRIOR TO VACCINE ADMINISTRATION. UPON PULLING THE NEEDLE OUT OF THE VIAL, THE NEEDLE BROKE OFF FROM THE HUB AND APPEARED BENT. INSPECTION OF THE NEEDLE PRIOR TO RECONSTITUTION INDICATED NO CONCERNS WITH NEEDLE INTEGRITY. THE VACCINE WAS WASTED DUE TO SAME AND A NEW NEEDLE FROM A DIFFERENT MANUFACTURER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035538 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "IN THE 2 WEEKS SINCE WE STARTED USING THESE DEVICES, I HAVE HAD SEVERAL NEAR MISSES. THE CAPS ARE DIFFICULT TO REMOVE, AND THE SAFETY IS CHALLENGING TO ENGAGE. TODAY, WHILE PROVIDING IMMUNIZATIONS IN A SCHOOL SETTING, I ADMINISTERED AN HBV VACCINE TO A STUDENT. WHILE I STRUGGLED TO ENGAGE THE SAFETY POST IMMUNIZATION, THE PHALANGE ON THE SYRINGE FELL OFF, THUS THE NEEDLE FELL AND PUNCTURED SKIN ON MY 2ND KNUCKLE ON MY RIGHT HAND."

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035529 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED: WHILE ADMINISTERING MENINGOCOCCAL CONJUGATE VACCINE ON CHILD'S LEFT ARM, VACCINE SPRAYED BACKWARDS THROUGH THE HUB OF NEEDLE - WHERE IT IS CONNECTED TO THE SYRINGE. VACCINE NOT ADMINISTERED TO CHILD. NEEDED TO BE READMINISTERED ON LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035523 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "CUSTOMER REPORTED: I WAS PREPARING TO IMMUNIZE A CLIENT IN AN OUTREACH CLINICAL SETTING. I APPLIED THE SOL-CARE SAFETY NEEDLE LDS 25G X 1 INCH NEEDLE TO THE HUB OF THE IMMUNIZATION SYRINGE AND ENSURED IT WAS SECURED. I PUSHED DOWN THE ORANGE PLASTIC SAFETY GLIDE TO BE ADJACENT TO THE BARREL OF THE SYRINGE. I HELD THE SYRINGE FIRMLY IN MY RIGHT HAND AND I ATTEMPTED TO LOOSEN THE CAP WITH MY LEFT HAND. THE CAP ON THE NEEDLE FELT STUCK TO THE BASE OF THE SAFETY GLIDE AND REQUIRED ME TO USE ADDITIONAL FORCE TO TUG THE CAP OFF. WHEN THE CAP GAVE IT CREATED ENOUGH PRESSURE TO PUSH THE NEEDLE DOWN, AND THIS RESULTED IN THE NEEDLE SCRATCHING MY LEFT PALM. THE CAP OF THE SOL-CARE SAFETY NEEDLE LDS 25G X 1 INCH IS COMPRISED OF THIN PLASTIC AND IT IS TIGHT TO THE NEEDLE. IT IS SOMEWHAT DIFFICULT TO HOLD THE CAP AND PULL COMPARED TO OTHER PRODUCT THAT HAVE A STURDIER CAP. THIS IS NOT THE FIRST TIME THE CAP ON THIS PRODUCT HAS BEEN RESISTENT TO BEING REMOVED BY ME IN PRACTICE, BUT IT IS THE FIRST TIME IT POPPED OFF IN SUCH A WAY THAT IT RESULTED IN ENOUGH FORCE TO PRESS THE NEEDLE DOWN AND INTO MY PALM.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035517 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  "CUSTOMER REPORTED: WRITER WAS DRAWING UP DTAP IPV HIB HB FOR A 4 MO. VISIT. THE CAP WAS DIFFICULT TO REMOVE FROM THE NEEDLE. WRITER WAS LOOSENING THE CAP ON THE NEEDLE BEFORE COMBINING THE DTAP IPV HB PORTION INTO THE HIB PORTION IN PREPARATION FOR VACCINATION. WITH A LOT OF EFFORT THE CAP WAS REMOVED AND THEN THE NEEDLE WAS TIGHTENED BY THE WRITER TO THE SYRINGE. WHEN THE LIQUID PORTION WAS PUSHED INTO THE HIB PORTION OF THE VACCINE FROM THE SYRINGE. THE LIQUID SPRAYED FROM THE HIB OF THE SYRINGE AND THE MIXING WAS NOT ABLE TO BE COMPLETED. THE VACCINE WAS RECORDED AS WASTED. THE NEEDLE LOT NUMBER IS 07107030. A NEW VACCINE SYRINGE AND NEEDLE WAS PRIMED AND THAT WAS DONE SUCCESSFULLY AND THE INFANT WAS VACCINATED."

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 22035515 ↗
• MalfunctionMay 16, 2025Decoupling; Decoupling

  "CUSTOMER REPORTED: SOL-CARE IM NEEDLE REF SN2510 USED FOR MENCON-C IMMUNIZATION. AT END OF IMMUNIZATION NEEDLE POPPED OFF OF SYRINGE. NEEDLE NEEDED TO BE MANUALLY REMOVED FROM INFANTS LEG. WRITER AND CLIENTS MOM NOTED THE FULL DOSE HAD GONE IN AND THERE WAS NO SPILLAGE NOR ANY INJURY TO THE CLIENT. WONDERING IF NEEDLE WAS BLOCKED CAUSING SEPARATION. OCCURRENCES: 1 EACH."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22035496 ↗
• MalfunctionMay 16, 2025Decoupling; Decoupling

  "CUSTOMER REPORTED: *CITE CUSTOMER COMPLAINT # (B)(4) AFTER IMMUNIZING A CLIENT WITH HPV VACCINE, WHILE PUTTING ON THE SAFETY, THE NEEDLE FLEW OFF THE END OF THE SYRINGE & LANDED ON THE FLOOR. THE SAFETY WAS ON JUST PRIOR TO DETACHMENT SO NO ONE WAS IMPACTED. THE SYRINGE APPEARED INTACT & THE NEEDLE WAS PROPERLY ATTACHED BY WRITER WHEN DRAWING UP. QUERY PRODUCT CONCERN WITH THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035456 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER REPORTED: STAFF NURSE WAS RE SHEATHING NEEDLE AFTER DRAWING UP VACCINE, NEEDLE WENT THROUGH THE CAP AND PUNTURED HER FINGER. (CLEAN NEEDLE) NEEDLE USED WAS SOL-CARE SAFETY NEEDLE. NURSE WASTED VACCINE. UNCERTAIN HOW NEEDLE PUNTURED THROUGH CAP AS NURSE HAS NEVER SEEN THIS BEFORE. TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE LEVEL OF HARM: NO APPARENT HARM.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035450 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  "CUSTOMER REPORTED: UPON ATTEMPT TO VACCINATE STUDENT, VACCINE SPRAYED OUT AROUND NEEDLE CONNECTION AND WAS NOT ADMINISTERED TO CLIENT. UNABLE TO MAINTAIN SECURE PLACEMENT WITH THE NEEDLE ON SLIP TIP SYRINGE. IMPACT OF INCIDENT: PATIENT REQUIRED ANOTHER DOSE, WHICH WAS ANOTHER INJECTION LEVEL OF HARM: MINIMAL HARM. OCCURRENCES: 1 EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035438 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED: AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024. INCIDENT DETAILS: ADMINISTERING DTAP VACCINE. INJECTION INTO CLIENT, VACCINE LEAKED ALL OUT FROM THE CONNECTION OF THE ORANGE SAFETY COVER TO THE NEEDLE HUB. SEAM INSIDE NEEDLE HUB LEAKED USING 'SOL CARE-SAFETY NEEDLE'. 1 INCH REF # (B)(4). LOT# 07108039 NEVER HAD THIS PROBLEM WITH USE OF BD SAFETY GLIDE NEEDLE. IMPACT OF INCIDENT: ADMINISTERED AN EFFECTIVE DOSE OF DTAP TO CLIENT LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035430 ↗