APEX™ 2112541Recalls & reported problems
B. Braun Medical Inc. · Universal Spikes (Singles) · 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 04046964688560), received between Jul 20, 2022 and Aug 11, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Component1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2022Leak/Splash; Leak/Splash
AS REPORTED PER MEDWATCH: DESCRIPTION: THE SPIKE PORT WAS FAULTY ON THE IV BAG RESULTING IN A CHEMO SPILL IN THE INFUSION CENTER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15208252 ↗MalfunctionJul 20, 2022Fluid/Blood Leak; Defective Component
THE SPIKE PORT WAS FAULTY ON THE IV BAG RESULTING IN A CHEMO SPILL IN THE INFUSION CENTER. OUR PHARMACY ONLY HAD ONE OTHER IV BAG WITH THIS SPECIFIC LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064945 ↗
Other Set, i.V. Fluid transfer devices
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- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.