Medline SYR103010Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 30080196310160), received between Jun 20, 2019 and Aug 27, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR INSIDE SYRINGE.

  Patient problems: Insufficient Information

  MAUDE report 20076380 ↗
• MalfunctionAug 8, 2024Connection Problem; Connection Problem

  SYRINGE DISCONNECTS FROM NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 19941085 ↗
• MalfunctionAug 7, 2024Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2024, "I WENT TO PUSH THE SYRINGE AFTER CHECKING THAT IT WAS ON SECURELY, THEN THE NEEDLE DISLODGED FROM THE SYRINGE MAKING THE MEDICATION SPILL EVERYWHERE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929632 ↗
• MalfunctionJun 18, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON 04/26/24 THE STAFF NURSE WAS "FLICKING AIR BUBBLES OUT OF THE SYRINGE AND THE ENTIRE TIP OF THE SYRINGE BROKE OFF COMPLETELY AND FELL DOWN INTO THE SYRINGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557789 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION LEAKED AROUND THE SYRINGE PLUNGER DURING AN INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016847 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "MEDICATION IS LEAKING AROUND THE PLUNGER" DURING USE OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009641 ↗
• MalfunctionMar 29, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE SYRINGE PLUNGER "KEEPS BENDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008738 ↗
• MalfunctionMar 29, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE SYRINGE PLUNGER "KEEPS BENDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008734 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "FLUID IS PUSHING BACKWARD THRU THE STOPPER" OF THE SYRINGE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001454 ↗
• MalfunctionMar 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SYRINGE HAD AN "ISSUE" WITH THE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001425 ↗
• MalfunctionMar 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SYRINGE "CAN DRAW THE MEDICATION UP BUT CANNOT PUSH IT BACK OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001399 ↗
• MalfunctionMar 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SYRINGE WAS RECEIVED UNATTACHED TO A NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967650 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLACK TIP OF THE SYRINGE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962565 ↗
• MalfunctionMar 22, 2024Contamination; Contamination

  IT WAS REPORTED THAT PARTICULATE WAS NOTED WITHIN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959902 ↗
• MalfunctionMar 18, 2024Contamination; Contamination

  IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922060 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT THE SYRINGE IS LEAKING AND THAT NEEDLES ARE "FALLING OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743413 ↗
• MalfunctionSep 25, 2020Contamination /Decontamination Problem

  PLASTIC SLIVER WAS FOUND FLOATING IN BARREL OF SYRINGE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10592674 ↗
• MalfunctionAug 16, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SYRINGE'S PLUNGER WAS UNABLE TO BE MOVED TO PUSH THE MEDICATION RESULTING IN THE PATIENT REQUIRING ADDITIONAL INTRAMUSCULAR INJECTIONS.

  Patient problems: No Code Available

  MAUDE report 8903347 ↗
• MalfunctionAug 15, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SYRINGES' PLUNGERS COME OFF WHEN ADMINISTERING MEDICATIONS. THE PATIENTS HAD TO RETURN AT A LATER DATE FOR ADDITIONAL MEDICATION ADMINISTRATION.

  Patient problems: No Code Available

  MAUDE report 8898742 ↗
• MalfunctionJun 20, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT TDAP VACCINE LEAKED FROM BEHIND AND ONTO THE PLUNGER OF THE 3 ML SYRINGE RESULTING IN PATIENT NOT RECEIVING THE FULL DOSE OF THE VACCINE. PATIENT WAS SCHEDULED TO RECEIVE ANOTHER DOSE OF THE VACCINE.

  Patient problems: No Code Available

  MAUDE report 8718878 ↗