ICU Medical B33902Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00887709071681), received between Jul 26, 2023 and Aug 9, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Material Separation; Material Separation

  THE INCIDENT INVOLVED A 13" SMALLBORE QUADFUSE EXTENSION SET W/3 MICROCLAVE (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER. THE CUSTOMER REPORTED THAT THE TUBING ADHESIVE DID NOT HOLD, AND THE TUBING PULLED APART FROM THE FILTER. THERE WAS UNKNOWN PATIENT INVOLVED NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487465 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES TWENTY OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421639 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES NINETEEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421638 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES THIRTEEN OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421637 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES TWELVE OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421636 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES EIGHTEEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421635 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES FOURTEEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421634 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES SIXTEEN OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421633 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES SEVENTEEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421632 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES FIFTEEN OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421631 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE (B)(6) THROUGH MID (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES ELEVEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421629 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES NINE OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421628 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES EIGHT OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421627 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES TEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421626 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES SEVEN OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421625 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES SIX OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421624 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES TWO OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421623 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES THREE OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421622 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE JUNE THROUGH MID JULY AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES FIVE OF TWENTY OCCURRENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421621 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES FOUR OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421620 ↗
• MalfunctionJul 30, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON FROM LATE (B)(6) AND INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER, WHERE IT WAS REPORTED THAT THEIR NICU HAD EXPERIENCED MALFUNCTIONS IN THE LAST 3 WEEKS RELATED TO A BROKEN FILTER. THE STATED ISSUE WAS PRODUCT DISCONNECTING/FALLING APART. THERE WAS LEAKING AND THE DEFECTIVE PRODUCT WAS INFUSING WITH FLUID, TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS. THERE WERE SEVERAL PATIENTS INVOLVED, NO PATIENT HARM BUT PATIENTS NEEDED SEPTIC WORK UPS, AND THERE WAS DELAY IN THERAPY AS ALL TUBING HAD TO BE CHANGED DELAYING ADMINISTRATION. THIS CAPTURES ONE OF TWENTY OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421619 ↗
• MalfunctionJul 26, 2023Crack; Fluid/Blood Leak; Separation Failure; Insufficient Device Problem Information; Crack; Fluid/Blood Leak; Separation Failure; Insufficient Device Problem Information

  UPDATED INFORMATION FROM THE CUSTOMER WAS RECEIVED ON 26-JUL-2023 STATING THAT THE INVOLVED LOT NUMBER IS 13605717 AND THAT THE PRODUCT WAS USED BEFORE THE ISSUE WAS NOTICED. THE DEFECTIVE PRODUCT WAS INFUSING WITH TPN AND LIPIDS WHEN LEAKAGE OCCURRED SEVERAL TIMES. THE PATIENT GENERATED POSITIVE BLOOD CULTURE TESTS, WHICH REQUIRED UNSPECIFIED MEDICAL INTERVENTION. ALTHOUGH THERE WAS A DELAY IN THERAPY WHILE THE TUBING WAS CHANGED OUT, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398377 ↗
• MalfunctionJul 26, 2023Material Separation; Material Separation

  THE EVENT INVOLVED A 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON FILTER, 4 CLAMPS, ROTATING LUER FROM WHICH THE FILTER HAD BEEN PULLED APART. THE CUSTOMER STATED THAT, WHEN A FILTER DISCONNECTS, THE LINE AND FILTER LAY IN AN OPEN BED FOR JUST A FEW MINUTES. A FEW MINUTES IS ALL IS NEEDED TO INTRODUCE A LIFE-THREATENING INFECTION TO A PREMATURE OR TERM NEONATE BECAUSE THEIR IMMUNE SYSTEMS ARE VERY UNDERDEVELOPED. WHEN THIS HAPPENS, THIS FACILITY'S NURSES COMPLETELY STOP THE FLUIDS AND ALSO CHANGE OUT THE LINES. EACH OF THE PATIENTS HAS TO RECEIVE A FULL SEPSIS LAB WORK-UP AND IF THE PATIENT STARTS SHOWING SIGN OF ILLNESS, THEN ANTIBIOTICS WOULD NEED TO BE STARTED. THE CUSTOMER STATED THAT THIS CAN BE VERY DANGEROUS FOR THE PATIENT AND ALSO CONCERNING FOR FAMILIES/OTHERS INVOLVED IN THE PATIENT'S CARE. THERE WAS NO REPORT OF SPECIFIC ACTUAL HUMAN HARM TO ANY PATIENT IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396976 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• Z-0237-2021 · Jul 6, 2020 · Terminated
  20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(1
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case

…and 173 more.