Medline SYR130010Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LUER LOCK, 30ML · 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 30080196310238), received between Mar 23, 2023 and Sep 30, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Contamination” (4 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
- Appropriate Device Problem Term/Code Not Available6
- Contamination4
- Crack4
- Break3
- Device Contaminated During Manufacture or Shipping1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Foreign Body In Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951368 ↗MalfunctionMay 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, "FOR THREE INCIDENTS, THE PLASTIC WHERE YOU PLACE YOUR TWO FINGERS BROKE OFF. THE PATIENT WAS NOT INJURED OR AFFECTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19241790 ↗MalfunctionMay 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, "FOR THREE INCIDENTS, THE PLASTIC WHERE YOU PLACE YOUR TWO FINGERS BROKE OFF. THE PATIENT WAS NOT INJURED OR AFFECTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19240988 ↗MalfunctionMay 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, "FOR THREE INCIDENTS, THE PLASTIC WHERE YOU PLACE YOUR TWO FINGERS BROKE OFF. THE PATIENT WAS NOT INJURED OR AFFECTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19240390 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047534 ↗MalfunctionApr 4, 2024Crack; Crack
IT WAS REPORTED THAT THE SYRINGE CRACKED "WHILE PULLING THE PLUNGER BACK OR FORTH TO PUSH MEDICATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039028 ↗MalfunctionApr 1, 2024Crack; Crack
IT WAS REPORTED THAT THE SYRINGE WAS "FAULTY AND CRACKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009639 ↗MalfunctionMar 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT ON 02/15/2024 WHILE "RITUXIMAB" WAS BEING DRAWN UP A "SUBSTANCE WAS FOUND FLOATING" IN THE SYRINGE BUT, THERE WAS "NO PATIENT INVOLVEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18975843 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE WAS NOTED WHEN DRAWING UP MEDICATION INTO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18968797 ↗MalfunctionMar 24, 2024Crack; Crack
IT WAS REPORTED THAT THE SYRINGE "CRACKED DOWN THE MIDDLE" DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966433 ↗MalfunctionMar 22, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961532 ↗MalfunctionMar 18, 2024Contamination; Contamination
IT WAS REPORTED THAT A "SQUARE PIECE OF MATERIAL" WAS NOTED IN THE SYRINGE AFTER DRAWING UP LIQUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922079 ↗MalfunctionMar 12, 2024Break; Break
ACCORDING TO THE CUSTOMER," WHEN APPLYING PRESSURE ON THE FLAP IT BREAKS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888741 ↗MalfunctionMar 12, 2024Break; Break
ACCORDING TO THE CUSTOMER," WHEN APPLYING PRESSURE ON THE FLAP IT BREAKS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888648 ↗MalfunctionMar 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO FACILITY ON (B)(6) 2024 THE THUMB TAB OF THE SYRINGE BROKE OFF WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18859329 ↗MalfunctionMar 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PHARMACIST NOTICED "EXCESS LUBRICATION" INSIDE OF THE SYRINGE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18855986 ↗MalfunctionFeb 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE SYRINGE BREAKS AT THE PLASTIC AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794591 ↗MalfunctionFeb 7, 2024Contamination; Contamination
IT WAS REPORTED THAT UNSPECIFIED "PARTICLES" WERE FOUND IN THE SYRINGE UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659092 ↗MalfunctionFeb 6, 2024Crack; Crack
IT WAS REPORTED THAT THE SYRINGE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655431 ↗MalfunctionJan 4, 2024Material Integrity Problem; Material Integrity Problem
MalfunctionMar 23, 2023Break; Break
PIECES BROKE OFF IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16601929 ↗
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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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