PhaSeal Optima 515063Recalls & reported problems
Becton Dickinson Pen Limited · PhaSeal Optima Protector (P28-O) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382905150630), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 16, 2025Open, Classified
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Z-2453-2025 · Root cause: Error in labeling · FDA record ↗
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.
MalfunctionOct 11, 2023Break; Break
IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA PROTECTOR P28-O THE DEVICE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AND WE HAD ANOTHER INCIDENT WHERE THE LARGER PROTECTORS ARE NOT EXPANDING. THIS TIME THE PROTECTOR ACTUALLY CRACKED WHERE THE PROTECTOR AND SYRINGE CONNECT AND SPRAYED CISPLATIN INTO THE HOOD BECAUSE THE AIR WENT INTO THE VIAL AND NOT THE PROTECTOR. BEAR IN MIND THIS IS ONLY HAPPENING WITH THE LARGER PROTECTORS AND IT'S NOT HAPPENING EVERY TIME WE UTILIZE THEM. HERE ARE THE STEPS WE ARE TAKING: DRAWING BACK TO ANYWHERE BETWEEN 30ML TO 40ML OF AIR LEAVING THE VIAL SITTING IN THE HOOD, DIRECTING AIR INTO THE PROTECTOR BALLOON DOES NOT EXPAND, THEREFORE GIVING US "PUSH BACK" AGAINST THE SYRINGE THIS TIME THE PUSH BACK CAUSED THE SNAPPING OF THE PROTECTOR AND SYRINGE AND SPRAYING CISPLATIN UNTIL THE VIAL EQUALIZED PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17916786 ↗
Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices
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- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.