Medline SYRI005314Recalls & reported problems
Medline Industries, Inc. · SYR W/NDLE,INSLN,0.5ML,31GX5/16" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489008630), received between Mar 24, 2024 and Aug 12, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Connection Problem1
- Contamination1
- Improper Flow or Infusion1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2024Connection Problem; Connection Problem
MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE SYRINGE-NEEDLE COMBO "TOOK A LONG TIME TO DRAW." ACCORDING TO THE REPORTING FACILITY, "PATIENTS COULD FEEL THE NEEDLE BEING INSERTED." TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834864 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT THE SYRINGE LEAKED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834772 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT THE SYRINGE HAD FOREIGN PARTICULATE AND "A LOT OF WASTED PRODUCT." NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR TO A USER WAS ORIGINALLY REPORTED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES.NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834768 ↗MalfunctionMar 24, 2024Contamination; Improper Flow or Infusion; Contamination; Improper Flow or Infusion
IT WAS REPORTED THAT THE SYRINGE HAD FOREIGN PARTICULATE AND "A LOT OF WASTED PRODUCT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966406 ↗MalfunctionMar 24, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SYRINGE LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966405 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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