TERUMO SS-20S2Recalls & reported problems
Terumo (Philippines) Corporation · TERUMO Syringe without Needle · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34806017511396), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2022Break; Break
THE USER FACILITY REPORTED THAT WHEN THE INVOLVED DEVICE WAS CONNECTED TO THE CUSTOMER FOR SALINE FLUSH THE SYRINGE BROKE OFF INTO THE HEMOCATHETER. IT REQUIRED FORCEPS TO REMOVE THE SYRINGE. THERE IS A POTENTIAL FOR AN INFECTION AND THERE IS DAMAGE TO THE HEMOCATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2022: THE DATE OF EVENT DATE REGARDING THE SYRINGE TIP BREAKING OFF DURING SALINE FLUSH AND RETAINED INSIDE HEMOCATHETER HAPPENED OVER 2-3 DAYS BEFORE WE WERE NOTIFIED OF THE ISSUE BY STAFF FEB 14-16TH. THE PATIENT PROCEDURE IS UNKNOWN DURING THIS TIME FRAME. THE ISSUE WAS RESOLVED DURING THE PROCEDURE ONCE THE TIP WAS REMOVED FROM THE PATIENT'S CENTRAL VENOUS CATHETER, ANOTHER BRAND OF A SYRINGE WAS USED TO CONTINUE THE PROCESS OF CONNECTING THE HEMODIALYSIS LINES TO THE CENTRAL LINE. THE PATIENT CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY WHEN THE ISSUE OCCURRED. BUT THERE WAS A POTENTIAL FOR INJURY WITH POSSIBLE AIR EMBOLI FROM AIR BEING ABLE TO LEAK FROM LOOSE CONNECTION AND POTENTIAL FOR BEING UNABLE TO USE THE CATHETER AND PATIENT BEING UNABLE TO GET LIFESAVING DIALYSIS TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04 MAR 2022: THE CHARACTERISTICS OF THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13942992 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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