BD PhaSeal 515301Recalls & reported problems
Becton Dickinson Pen Limited · Secondary Set, Drip Chamber (C60) · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382905153013), received between Aug 29, 2018 and Aug 29, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2018Leak/Splash
IT WAS REPORTED THAT BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60 ARE LEAKING WHERE THE BAG IS SPIKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7828423 ↗MalfunctionAug 29, 2018Leak/Splash
IT WAS REPORTED THAT A BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60 HAD ROLLER CLAMP THAT DID NOT FULLY ENGAGE AND LEAKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7828103 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.