TERUMO SS-03L2516Recalls & reported problems
Terumo (Philippines) Corporation · TERUMO Syringe with Needle · Class 2
Data updated Oct 18, 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 34806017511198), received between Jun 7, 2024 and Jun 7, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Break; Break
THE USER FACILITY REPORTED THAT WHEN INJECTING PRE-OPERATIVE MEDICATION, THE 25G 5/8 NEEDLE (TERUMO SYRINGE WITH NEEDLE LOT 230116M) BROKE AT THE BASE. INTRAMUSCULAR INJECTION OF (KETAMINE/VETERGESIC/DEXDOMITOR) LIQUID CONSISTENCY. THE PATIENT WAS SENT FOR X-RAYS ELSEWHERE DUE TO NO MACHINE PRESENT. THE X-RAYS CONFIRMED THAT THE NEEDLE WAS PRESENT IN THE PATIENT'S RIGHT THIGH. THE DOCTOR ATTEMPTED TO FIND THE NEEDLE VIA SURGERY; HOWEVER, WAS NOT SUCCESSFUL. THE PATIENT WAS REFERRED FOR ECHO SURGERY GUIDED OPERATING ROOM TO SEE SPECIALISTS. THE PATIENT'S CONDITION WILL BE MONITORED TO ASSESS WHETHER THE NEEDLE MIGRATED. FRIDAY AFTERNOON ((B)(6)) THE DOCTOR ASKED TO CARRY OUT X-RAYS AND SURGERY TO ATTEMPT TO TURN TO REMOVE THE NEEDLE. THERE WAS NO BLOOD LOSS. THE EVENT RESULTED IN INJURY. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 24 MAY 2024: ON FRIDAY (B)(6), THE CANNULA WAS REMOVED AT THE HOSPITAL AFTER TWO (2) HOURS OF EXPLORATORY SURGERY. THE PATIENT WAS DOING WELL, AND EVERYTHING WAS FINE. ON MONDAY MORNING, THE PATI
Patient problems: Foreign Body In Patient
MAUDE report 19483525 ↗
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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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