Cadence Science® 5340Recalls & reported problems
Cadence Science, Inc. · Pressure Control 3mL in 1/5mL, Lock Tip · 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 00816329023404), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2019Fracture; Fracture
THE GLASS SYRINGE BROKE AT THE TOP FLANGE WHERE THE PRESSURE CONTROL RINGS ATTACH TO THE GLASS. THE CUSTOMER REPORTED THAT WHILE IN SURGERY, SCRUB TECH DREW UP LIDOCAINE AND HANDED THE GLASS SYRINGE TO THE SURGEON. THE SURGEON INJECTED THE PATIENT AND WHEN PRESSURE WAS APPLIED TO ADMINISTER THE MEDICATION, WHERE THE RINGS ATTACH TO THE VIAL "POPPED" APART. NO PATIENTS HAVE BEEN HARMED. THE SYRINGE ITSELF DOESN'T BREAK/SHATTER - THE RING THAT HAS THE 2 LOOPS BREAKS AWAY FROM THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8457996 ↗
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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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