Medline SYR105010Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LUER LOCK, 5ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30080196310177), received between Aug 21, 2019 and Jun 18, 2024 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
- Contamination7
- Material Integrity Problem3
- Connection Problem1
- Detachment of Device or Device Component1
- Leak/Splash1
- Material Fragmentation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Needle Stick/Puncture1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY A HOLE IN THE SYRINGE WAS FOUND WHILE USING ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558087 ↗MalfunctionMay 1, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON 04/03/24 "WING OF THE SYRINGE BROKE OFF WHEN ATTEMPTING TO INJECT BUPIVACAINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19222667 ↗MalfunctionApr 25, 2024Material Integrity Problem; Material Integrity Problem
MalfunctionApr 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE PLUNGER "GETS STUCK" AND WAS DIFFICULT TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046485 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046385 ↗MalfunctionApr 3, 2024Contamination; Contamination
IT WAS REPORTED THAT A "PLASTIC SHRED / STRING" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038471 ↗MalfunctionApr 3, 2024Break; Break
IT WAS REPORTED THAT THE SYRINGE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038469 ↗MalfunctionApr 2, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016921 ↗MalfunctionMar 25, 2024Break; Break
IT WAS REPORTED THAT THE SYRINGE BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18975568 ↗MalfunctionMar 25, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE "TOP WING" OF THE SYRINGE BROKE OFF DURING AN INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18968789 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966556 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966435 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED THAT "ONE OF THE WINGS" OF THE SYRINGE BROKE WHILE INJECTING BUPIVACAINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922296 ↗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 18922218 ↗MalfunctionMar 18, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE AFTER DRAWING UP FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922120 ↗MalfunctionMar 18, 2024Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT A NEEDLE DID NOT "TIGHTEN DOWN" WITH THE SYRINGE AND THAT DETACHMENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921985 ↗MalfunctionMar 18, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT LEAKAGE OCCURRED WITH THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921844 ↗MalfunctionFeb 22, 2024Break; Break
IT WAS REPORTED THAT THE SYRINGE BROKE DURING AN UNSPECIFIED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18763964 ↗MalfunctionFeb 22, 2024Break; Break
IT WAS REPORTED THAT THE SYRINGE BROKE DURING AN UNSPECIFIED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18763950 ↗MalfunctionFeb 7, 2024Break; Break
IT WAS REPORTED THAT "THE WINGS OF THE SYRINGE SNAPPED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659091 ↗MalfunctionAug 21, 2019Break
IT WAS REPORTED THAT THE PLUNGER OF THE SYRINGE BROKE AT THE BEGINNING OF THE PROCEDURE RESULTING IN A NEW SYRINGE TO COMPLETE THE PROCEDURE. .
Patient problems: Needle Stick/Puncture
MAUDE report 8915646 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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