BD PhaSeal Optima 515628Recalls & reported problems
BD Switzerland Sàrl · BD Phaseal™ Optima Spike Set (C180-O) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382905156281), received between Jan 8, 2026 and Sep 28, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash7
- Break1
- Contamination1
- Disconnection1
- Loose or Intermittent Connection1
- Material Deformation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921295 ↗MalfunctionSep 24, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892039 ↗MalfunctionApr 2, 2026Material Deformation
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER TRIED TO PUNCTURE A 515628 INTO A THERMO RAW FOOD AND THE RUBBER STOPPER GOUGED OUT DURING USE. THE SUBJECT 515628 SEEMS TO HAVE BEEN DISCARDED. ADDITIONAL INFORMATION PROVIDED: CUSTOMER RESPONSE: Q: CAN YOU CHECK FOR LEAKS? A: CONFIRMED, THERE IS LEAKAGE. Q: DID YOU HAVE ANY PROBLEMS INSERTING THE SPIKE INTO THE IV BAG? A: AS USUAL, STRONG FORCE WAS REQUIRED AT THE TIME OF PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765096 ↗MalfunctionFeb 26, 2026Nonstandard Device
ADDITIONAL DETAILS REQUESTED: WAS THERE ANY FRAGMENTS OBSERVED WITHIN THE IV BAG? WHAT BRAND IV BAG/BOTTLE WAS USED? WHY WAS THE SPIKE REMOVED? PER RESPONSE: 1. NOT FOUND. 2. TERUMO. 3. I DON'T THINK IT WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455047 ↗MalfunctionFeb 20, 2026Leak/Splash
IT WAS REPORTED THAT THE BD SPIKE SET C180-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF ANTICANCER DRUG, THE ANTICANCER DRUG LEAKED OUT FROM THE SITE WHERE THE INFUSION BAG WAS PUNCTURED, AND THE ANTICANCER DRUG SEEPED THROUGH THE ROUTE AND ONTO THE BEDSIDE. DIBUTANAT LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408180 ↗MalfunctionFeb 20, 2026Leak/Splash
IT WAS REPORTED THAT THE BD SPIKE SET C180-O HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE DRUG LEAKED OUT FROM PUNCTURE SITE OF SPIKE WHILE ADMINISTERING SOLDEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408177 ↗MalfunctionFeb 11, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317061 ↗MalfunctionFeb 9, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300302 ↗MalfunctionFeb 2, 2026Leak/Splash
EVENT DETAILS: IT WAS REPORTED THAT THE DRUG STARTED LEAKING OUT WHILE PUNCTURING THE SPIKE DURING PREPARATION OF DOCETAXEL. THE INFUSION BAG IS A SALINE SOLUTION FROM KOSHA. THE INJECTOR (CONTAINING DOCETAXEL) WHEN IT WAS BEING PREPARED IS ALSO ENCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233588 ↗MalfunctionFeb 2, 2026Leak/Splash
EVENT DETAILS: IT WAS REPORTED THAT WHEN A SPIKE WAS PUNCTURED INTO THE INFUSION SET, THE MEDICATION LEAKED OUT FROM THE SIDE WHERE THE SPIKE WAS PUNCTURED. (INFUSION BOTTLE TERUMO SOLDEM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233450 ↗MalfunctionJan 14, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075275 ↗MalfunctionJan 9, 2026Leak/Splash
EVENT DETAILS: IT WAS IDENTIFIED THAT THE LEAK WAS BETWEEN THE BAG STOPPER AND THE C180-O SPIKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027269 ↗MalfunctionJan 8, 2026Disconnection
EVENT DETAILS: IT WAS REPORTED THAT DURING USE THE SPIKE SET FELL OUT OF THE INFUSION BOTTLE EASILY. A SMALL AMOUNT OF PHYSIOLOGICAL SALINE SOLUTION LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004861 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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