Zyno BX-70071-DRecalls & reported problems
Zyno Medical LLC · BX Administration Primary Set: 105" 1 NF Y-Site Below Pump, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00814371020532), received between Jun 29, 2020 and Jul 9, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak6
- Leak/Splash3
- Detachment of Device or Device Component2
- Air/Gas in Device1
- Manufacturing, Packaging or Shipping Problem1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770352 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED TO INTUVIE THAT A MALFUNCTION OCCURRED WITH A BATCH OF TUBING DURING THE INFUSION OF MEDICATION TO A PATIENT. THIS HAPPENED IN THE MIDDLE OF THE INFUSION. ATTACHED IMAGES WERE PROVIDED FOR REFERENCE. AS A PRECAUTION, ALL TUBING FROM THIS LOT NUMBER WAS REMOVED FROM THE REPORTER¿S CURRENT INVENTORY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173007 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED TO INTUVIE THAT A MALFUNCTION OCCURRED WITH A BATCH OF TUBING DURING THE INFUSION OF MEDICATION TO A PATIENT. THIS HAPPENED IN THE MIDDLE OF THE INFUSION. ATTACHED IMAGES WERE PROVIDED FOR REFERENCE. AS A PRECAUTION, ALL TUBING FROM THIS LOT NUMBER WAS REMOVED FROM THE REPORTER¿S CURRENT INVENTORY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172944 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO INTUVIE THAT ¿LOT 2404016 HAS BEEN REPORTED TO CONTAIN MORE AIR BUBBLES THAN USUAL¿. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT OR USER HARM WAS REPORTED. A REVIEW OF THE LOT# HISTORY FOR LOT 2404016 REVEALED NO SIMILAR COMPLAINTS. THE IV SET TUBING WAS NOT RETURNED TO INTUVIE FOR EVALUATION. THE COMPLAINT WAS CONFIRMED; HOWEVER, THE PROBABLE CAUSE COULD NOT BE DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880127 ↗MalfunctionDec 22, 2025Separation Problem; Separation Problem
IT WAS REPORTED TO INTUVIE THAT ¿THE VENT COVER FALLS OFF WHEN TRYING TO OPEN IT WHEN GIVING INTRAVENOUS IMMUNOGLOBULIN (IVIG)¿. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT OR USER HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871689 ↗MalfunctionJul 29, 2025Leak/Splash; Leak/Splash
INTUVIE RECEIVED A REPORT INDICATING THAT THE PATIENT'S IV TUBING EXHIBITED A MANUFACTURING DEFECT AT THE Y-SITE PORT, WHICH RESULTED IN A LEAK. AS A CONSEQUENCE OF THE DEFECT, 8 VIALS OF THE MEDICATION REMICADE WERE LOST DUE TO LEAKAGE AND COULD NOT BE ADMINISTERED TO THE PATIENT. NO PATIENT OR USER HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649875 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON 01/14/2020, A USER FACILITY REPRESENTATIVE REPORTED A COMPLAINT THAT "AN ADMINISTRATION SET MODEL N/A LOT # ALSO N/A IS LEAKING RIGHT BELOW THE DRIP CHAMBER. THIS HAPPENED THREE SEPARATE TIMES AND ONE OF THE SETS IS BEING DISCARDED." A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS SALINE AND IRON SUCROSE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD. THIS COMPLAINT WAS DETERMINED AS REPORTABLE DURING A RETROSPECTIVE REVIEW PERFORMED IN (B)(6) 2022. THIS MDR IS BEING SUBMITTED AS PART OF REMEDIATION ACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15522115 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
ON ((B)(6)2020, A USER FACILITY REPRESENTATIVE REPORTED A COMPLAINT THAT "AN ADMINISTRATION SET MODEL N/A LOT # ALSO N/A IS LEAKING RIGHT BELOW THE DRIP CHAMBER. THIS HAPPENED THREE SEPARATE TIMES AND ONE OF THE SETS IS BEING DISCARDED." A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS SALINE AND IRON SUCROSE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (B)(6) MEDICAL CO. LTD. THIS COMPLAINT WAS DETERMINED AS REPORTABLE DURING A RETROSPECTIVE REVIEW PERFORMED IN SEPETEMBER 2022. THIS MDR IS BEING SUBMITTED AS PART OF REMEDIATION ACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15521223 ↗MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00017).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11528194 ↗MalfunctionJan 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00057).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11215422 ↗MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00039).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10953598 ↗MalfunctionNov 17, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00036).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10856033 ↗MalfunctionJun 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THIS IS THE THIRD MDR FOLLOW UP FOR THE INITIALLY FILED MDR (3006575795-2020-00007).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10209695 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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