Spike Coupler 2S-P20Recalls & reported problems
Origen Biomedical, Inc. · Two spikes to one spike port with 20cm SCD tubing and pinch clamps · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10816203020021), received between Mar 15, 2024 and Mar 15, 2024 — classified as 1 malfunction.
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
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.
MalfunctionMar 15, 2024
DURING A CELLULAR TRANSPLANT A ¿T-CONNECTOR/SPIKE ADAPTER¿ WAS BEING USED AND WHILE TRYING TO CHANGE OUT THE BAG OF CELLS, ONE OF THE SPIKES BROKE OFF INTO THE CELL BAG. A NEW T-CONNECTOR WAS USED AND DURING CELLULAR INFUSION TAKEDOWN THE SAME THING HAPPENED WHERE ONE OF THE SPIKES BROKE OFF INTO THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911824 ↗
Other Tube, Tissue Culture devices
- 6ml Syringe to SCD Tube Accessory Set RF-T15Origen Biomedical, Inc. · Tube, Tissue Culture1 recall2 reports
- 60ml Syringe, FLL X SCD 15-RF60-TOrigen Biomedical, Inc. · Tube, Tissue Culture1 recall0 reports
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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