Lifeshield 1266428Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10887787005964), received between Jun 22, 2023 and Jun 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Backflow” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562311 ↗
• MalfunctionJun 8, 2026Particulates

  AN EVENT INVOLVED AN NDEHP PRIM PBK SET 3CLAVE-SL, REPORTING THAT THE IV TUBING WAS FOUND TO BE CONTAMINATED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427769 ↗
• MalfunctionApr 22, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THE COMPLAINT/EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH. IT WAS REPORTED THAT FLUID JUST KEEPS ON RUNNING OUT WHEN THEY SPIKE THE INFUSION BAG. FURTHER, THERE WAS NO WHEEL TO PINCH THE TUBING PRESENT ON THE DEFECTIVE DEVICE. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883260 ↗
• MalfunctionJan 20, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH. IT WAS REPORTED THE PATIENT ARRIVED TO OR WITH IV FLUID RUNNING. DURING INTUBATION, IV TUBING WAS FOUND TO BE DEFECTIVE AS IV MEDS WERE BACKFLOWING OUT OF THE PROXIMAL IV PORT. ANESTHESIA REALIZED AFTER GIVING ROCURONIUM AND PROPOFOL. UNSURE HOW MUCH MEDICATION PT RECEIVED DUE TO MEDS COMING OUT OF PROXIMAL PORT. WRITER INFORMED PREP ROOM NURSE OF IV MALFUNCTION. THE PRODUCT WAS USED FOR TWO WEEKS BEFORE THE PROBLEM OCCURRED. THE PROBLEM WAS DISCOVERED BY AN OR RN. THE DEVICE WAS RE-STERILIZED OR RE-PROCESSED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. THEY HAVE TWO DOCUMENTED CASES THAT BOTH HAVE THE SAME EXACT ISSUE. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193259 ↗
• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH. THE CUSTOMER REPORTED THAT THE DEVICE IS LEAKING MEDICATION AND THEN THEY HAVE TO STOP THE SURGERY, BECAUSE THEY ARE NOT SURE HOW MUCH ANESTHETIC THE PATIENT HAS RECEIVED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951404 ↗
• MalfunctionOct 5, 2023No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH WHERE THE CUSTOMER REPORTED A FLOW ISSUE ON IV PRIMARY SET DURING INFUSION OF LACTATED RINGER¿S SOLUTION. ONCE CONNECTED TO AN IV, EVEN WITH THE ROLLER BALL CLAMP COMPLETELY OPEN, NO FLUID WAS FLOWING. ONCE IN THE OPERATING ROOM (OR), THEY TRIED A DIFFERENT TUBING, AND INTRAVENOUS (IV) AND IT WORKED. ADDITIONALLY, THE CUSTOMER REPORTED THAT THAT THE IV WAS PLACED AND PRIMARY TUBING ATTACHED. A STAFF NOTICED THAT THE TUBING ROLLER BALL CLAMP WASN¿T FLOWING, EVEN THOUGH IT WAS COMPLETELY OPEN. THE TUBING WAS CHANGED OUT FROM THE SAME LOT NUMBER, AND STILL NO IV FLUID WAS FLOWING. A NEW IV HAD TO BEEN INSERTED, RESULTING IN A SECOND NEEDLE ATTEMPT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877449 ↗
• MalfunctionOct 5, 2023No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH WHERE THE CUSTOMER REPORTED A FLOW ISSUE ON IV PRIMARY SET DURING INFUSION OF LACTATED RINGER¿S SOLUTION. ONCE CONNECTED TO AN IV, EVEN WITH THE ROLLER BALL CLAMP COMPLETELY OPEN, NO FLUID WAS FLOWING. ONCE IN THE OPERATING ROOM (OR), THEY TRIED A DIFFERENT TUBING, AND INTRAVENOUS (IV) AND IT WORKED. ADDITIONALLY, THE CUSTOMER REPORTED THAT THE IV WAS PLACED AND PRIMARY TUBING ATTACHED. A STAFF NOTICED THAT THE TUBING ROLLER BALL CLAMP WASN¿T FLOWING, EVEN THOUGH IT WAS COMPLETELY OPEN. THE TUBING WAS CHANGED OUT FROM THE SAME LOT NUMBER, AND STILL NO IV FLUID WAS FLOWING. A NEW IV HAD TO BEEN INSERTED, RESULTING IN A SECOND NEEDLE ATTEMPT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877444 ↗
• MalfunctionSep 7, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THE REPORTED COMPLAINT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH. IT WAS REPORTED THAT THE BACKCHECK VALVE DID NOT WORK AND IT ALLOWED UNSPECIFIED MEDICATION TO GO UP TO THE BAG, RATHER THAN TO THE PATIENT. THIS HAPPENED AFTER THE BACKCHECK VALUE WAS CHANGED TO THE DARK BLUE AND CLEAR. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699673 ↗
• MalfunctionJun 22, 2023Backflow; Backflow

  THE EVENT INVOLVED PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE END USER HAD AN ISSUE WITH ANTIBIOTICS BACKING UP INTO THE DRIP CHAMBER AFTER INJECTING INTO THE UPPER CLAVE Y-SITE. THERE IS PATIENT INVOLVEMENT HOWEVER NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182249 ↗