SPIKE ADAPTERRecalls & reported problems across all models

We found 2 models of SPIKE ADAPTER by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2022 and Oct 30, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SPIKE ADAPTER recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 26, 2023Open, Classified

   Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

   Z-0130-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 26, 2023Open, Classified

   Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

   Z-0129-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported SPIKE ADAPTER problems

SPIKE ADAPTER models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SPIKE ADAPTER 418121

  Set, administration, intravascular
  2 recalls0 reports
• SPIKE ADAPTER 418105

  Set, administration, intravascular
  2 reports

Recent SPIKE ADAPTER adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: WE HAD SEVERAL ISSUED USING YOUR VENTED SPIKE CONNECTOR WITH INVOLVED THE SECONDARY LINE RUNNING DRY DESPITE THERE STILL BEING FLUID IN THE GLASS BOTTLE. THE PUMP PULLED FROM THE PRIMARY LINE AND RAN IT DRY, LEAVING THE GLASS BOTTLE STILL FULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571115 ↗
• MalfunctionDec 8, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "OUR NURSES ARE REPORTING ERRORS WITH THE B BRAUN MACHINES. IT IS GIVING THEM RECURRING ERRORS WITH IVIGS AND THE ERROR MESSAGE IS "UPSTREAM OCCLUSION". THEY TRY MULTIPLE METHODS TO TRY TO CLEAR IT AND IT IS DELAYING PATIENT CARE. ALSO SOME MEDICATIONS CREATE BUBBLES AND AN ERROR "EXCEEDED AIR LIMIT" COMES UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947384 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls