MaxZero MZ5303Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, IV connector 17 cm (7.0 in) · Class 2
Quick summary
This BD MaxZero pressure extension set, an IV tubing connector, has 119 adverse event reports, with no injuries and no deaths. Many describe leaks at the connection and material separating, and some describe loose connections, blockages or contamination. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10885403230561), received between Oct 25, 2019 and Sep 22, 2026 — classified as 121 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (64 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash64
- Material Separation20
- Loose or Intermittent Connection14
- Device Contamination with Chemical or Other Material10
- Complete Blockage7
- Disconnection6
- Fluid/Blood Leak5
- Backflow4
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Consequences Or Impact To Patient16
- No Patient Involvement6
- Insufficient Information3
- Air Embolism1
- No Information1
- No Known Impact Or Consequence To Patient1
- Overdose1
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Complete Blockage
It was reported, Maxzero, occlusion, during use.The following was provided by the initial reporter: after connecting the B. Braun Discofix to an MZ5303, the anesthesiologist was unable to inject anything. He showed me the issue, and we tried several times¿including attempting to screw the set on more tightly. He noted that this was already the second time it had happened and pointed out the danger involved: if there were an urgent need to administer a rapid injection during surgery, the IV line would fail to work. This is not the first complaint in Belgium regarding IV connections and our Max Zero portfolio.Additional information:Was there any patient impact? The Max Zero was attached to a patient's catheter, and the B. Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm how the fault was identified? The Max Zero was attached to a patient's catheter, and the B. Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm the make and model of the connecting product(s) to the MaxZero extension? See attachment; I had already uploaded this photo to the PIR.Please confirm the exact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854443 ↗MalfunctionSep 22, 2026Complete Blockage
It was reported, Maxzero, occlusion, during use.The following was provided by the initial reporter: after connecting the B. Braun Discofix to an MZ5303, the anesthesiologist was unable to inject anything. He showed me the issue, and we tried several times¿including attempting to screw the set on more tightly. He noted that this was already the second time it had happened and pointed out the danger involved: if there were an urgent need to administer a rapid injection during surgery, the IV line would fail to work. This is not the first complaint in Belgium regarding IV connections and our Max Zero portfolio.additional information:Was there any patient impact ? The Max Zero was attached to a patient's catheter, and the B. Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm how the fault was identified? The Max Zero was attached to a patient's catheter, and the B. Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm the make and model of the connecting product(s) to the MaxZero extension? See attachment; I had already uploaded this photo to the PIR.Please confirm the exact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853264 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Loose or Intermittent Connection
It was reported that the BD MaxZero Pressure Rated Extension Set had connection issues.The following information was provided by the initial reporter: A Cathena IV was placed and a Maxzero extension set was connected. The connection would not seal properly and blood leaked at the connection until the extension set was replaced.Extension Set Product Information:Material Number: MZ5303.Material Description: BD MaxZero.Batch Number: 26045881.Additional Information Received from the Customer:Can you please provide an exact date of event in this format MM-DD-YYYY? Date was 08-27-2026.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event. Minor blood loss (only a few mL), delay to blood sample collection and saline infusion, extension set had to be replaced with another one from the same lot.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840322 ↗MalfunctionApr 30, 2026Fluid/Blood Leak
IT IS REPORTED, BLOOD AND NACL LEAKED BELOW THE VALVE, AT THE CONNECTION WITH THE TUBING. ADDITIONAL INFORMATION: NO CONSEQUENCES FOR THE PATIENT. DEVICE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049774 ↗MalfunctionApr 9, 2026Disconnection
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THIS IS A REPORT ABOUT CLOG IN CATHETER LUMEN. ACCORDING TO THE CUSTOMER¿S REPORT, A CLOG OCCURRED IN THE CATHETER LUMEN BEFORE USE. CONTAMINATED WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832434 ↗MalfunctionMar 30, 2026Loose or Intermittent Connection
IT WAS REPORTED, POOR CONNECTION; IT CONNECTED FIRMLY BUT ROTATED BACKWARD DURING USE. ADDITIONAL INFORMATION: HOW CAN I IDENTIFY THE FAILURE? CHECK ROTATION WHEN CONNECTED. WAS THE FAILURE IDENTIFIED DURING PRIMING OR INFUSION? IF DURING INFUSION, HOW LONG AFTER THE INFUSION STARTED? AT THE TIME OF CONNECTION PLEASE CONFIRM WHAT SUBSTANCE WAS BEING INFUSED AT THAT TIME. UNKNOWN AT PRESENT WAS THERE ANY HARM TO THE PATIENT? NONE. WAS THE AMOUNT INJECTED INSUFFICIENT? NO, WE WERE NOT TOLD THAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729428 ↗MalfunctionMar 24, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675828 ↗MalfunctionMar 5, 2026Fracture
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524203 ↗MalfunctionJan 30, 2026Material Separation
THE SAMPLE AVAILABLE FOR ANALYSIS WAS USED, THEN DISINFECTED WITH DDN9 PRE-DISINFECTION FOR 15 MINUTES. THERE IS NO VISIBLE DAMAGE. THE PATIENT WAS NOT INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223357 ↗MalfunctionNov 25, 2025Backflow; Leak/Splash; Backflow; Leak/Splash
IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2025, IN WARD M6, A NURSE WAS ADMINISTERING AN IV TO A PATIENT AND USED A BRAND NEW TRANSPARENT NEEDLELESS CONNECTOR. DURING USE, IT WAS DISCOVERED THAT THE NEEDLELESS CONNECTOR WAS BLOCKED, RESULTING IN UNSUCCESSFUL AIR VENTING AND RENDERING IT UNUSABLE. AFTER REPLACING IT WITH A NEW TRANSPARENT NEEDLELESS CONNECTOR, AIR VENTING WAS UNOBSTRUCTED, AND IT COULD BE USED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641290 ↗MalfunctionOct 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
EVENT DETAILS: WHEN CONNECTING MZ5303 TO THE HUB OF AN INDWELLING IV CATHETER, THERE IS NO CONNECTION BECAUSE THE MALE LOCKING PART WAS SPINNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297709 ↗MalfunctionOct 15, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23280633 ↗MalfunctionSep 4, 2025Backflow; Backflow
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: BACKFLOW. WHEN I WAS USING THE MAX EXTENSION TUBE TO LOCK SALINE, I SUDDENLY NOTICED BACKFLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22969106 ↗MalfunctionAug 22, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22878208 ↗MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INJECTION OF MEDICATION, THE PRODUCT LEAKED AT THE LUER LOCK. THE EXTENSION WAS CUT AND A NEW CATHETER WAS INSERTED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU CONFIRM HOW THE DEFECT WAS IDENTIFIED? THE DEFECT WAS IDENTIFIED WHEN SODIUM CHLORIDE WAS INJECTED INTO THE PATIENT, AT WHICH POINT THE DEPARTMENT BECAME AWARE OF THE LEAK. COULD YOU CONFIRM WHEN THE DEFECT WAS IDENTIFIED, DURING PRIMING OR DURING INFUSION? IF IT OCCURRED DURING INFUSION, AT WHAT POINT? DURING INFUSION, AT THE TIME OF INJECTION. COULD YOU CONFIRM WHETHER THERE IS ANY VISIBLE DAMAGE TO THE DEVICE, SUCH AS CRACKS, CHIPS OR DEFORMATION OF THE PISTON? UPON RECEIPT OF THE DEVICE, WE NOTICED THAT THE LUER LOCK WAS ¿MISALIGNED¿. COULD YOU CONFIRM WHAT SUBSTANCE WAS BEING INFUSED AT THE TIME OF THE INCIDENT? I BELIEVE IT WAS SODIUM CHLORIDE. DID THE PATIENT SUFFER ANY HARM? THE PATIENT HAD TO BE REINFUSED. WAS THE USER PRESENT AND ABLE TO INTERVENE AT THE TIME OF THE INCIDENT? THE USER WAS PRESENT AND INTERVE
Patient problems: Insufficient Information
MAUDE report 22606066 ↗MalfunctionJul 23, 2025Backflow; Backflow
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKAGE WAS NOTED AT CONNECTION SITE TO THE HUB OF THE IV CATHETER. ALSO NOTED THAT THERE WAS BACK FLOW EVEN THOUGH THE IV SOLUTION WAS FLOWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579484 ↗MalfunctionJul 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKAGE WAS NOTED AT CONNECTION SITE TO THE HUB OF THE IV CATHETER. ALSO NOTED THAT THERE WAS BACK FLOW EVEN THOUGH THE IV SOLUTION WAS FLOWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579476 ↗MalfunctionMay 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE HUB DOESN'T SEEM TO BE SCREWING IN TIGHT AND JUST KEEPS TWISTING AND NOT TIGHTENING, FLUID IS LEAKING OUT OF THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002489 ↗MalfunctionApr 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LOOSE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IV CONNECTORS ARE COMING LOOSE CAUSING THE IV TO LEAK ALL OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919614 ↗MalfunctionDec 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THIS IS A COMPLAINT ABOUT THE LOOSE CONNECTION. WHEN THE CUSTOMER USED A MAX ZERO EXTENSION TUBE, THEY CONNECTED THE MALE PART OF THE EXTENSION TUBE FROM TERUMO TO THE FEMALE PART OF THE MAX ZERO TO ADJUST THE LENGTH. THERE WAS NO PROBLEM WHEN THEY CONNECTED IT, BUT AFTER A WHILE IT BECAME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863547 ↗MalfunctionOct 27, 2024Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION: CAN YOU CONFIRM THE INFUSION CONFIGURATION - GRAVITY OR PUMP, INFUSION LINE HEIGHT, PATIENT ENTRY POINT, INFUSION FLOW RATE AND PRESSURE, INFUSION LINE CONFIGURATION (OTHER EXTENSIONS OR ACCESSORIES), ETC.? NORMAL INFUSION LINE HEIGHT (ON PATIENT'S ARM). ENTRY POINT ON FOREARM. NO EXTENSIONS OR ACCESSORIES. CAN YOU CONFIRM THE PRESENCE OF VISIBLE DAMAGE TO THE DEVICE, SUCH AS CRACKS, SPLINTERS OR DEFORMATION OF THE PLUNGER? NO VISIBLE DAMAGE, BUT DIFFICULTY SCREWING IN CAN YOU CONFIRM WHICH SUBSTANCE WAS BEING INFUSED AT THE TIME OF THE EVENT? SALINE SOLUTION CAN YOU CONFIRM WHETHER THE FAULT WAS IDENTIFIED DURING PRIMING OR INFUSION? IF DURING INFUSION, FOR HOW LONG? DURING INFUSION, 5MIN. CAN YOU CONFIRM THE DATE OF THE THIRD EVENT? WE HAVE THE 12/09 AND THE 27/09/24, COULD YOU PLEASE SPECIFY THE DATE OF THE 3RD EVENT? 1 EVENT ON 12/09 + 2 EVENTS ON 27/09.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541694 ↗MalfunctionOct 27, 2024Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION: CAN YOU CONFIRM THE INFUSION CONFIGURATION - GRAVITY OR PUMP, INFUSION LINE HEIGHT, PATIENT ENTRY POINT, INFUSION FLOW RATE AND PRESSURE, INFUSION LINE CONFIGURATION (OTHER EXTENSIONS OR ACCESSORIES), ETC.? NORMAL INFUSION LINE HEIGHT (ON PATIENT'S ARM). ENTRY POINT ON FOREARM. NO EXTENSIONS OR ACCESSORIES. CAN YOU CONFIRM THE PRESENCE OF VISIBLE DAMAGE TO THE DEVICE, SUCH AS CRACKS, SPLINTERS OR DEFORMATION OF THE PLUNGER? NO VISIBLE DAMAGE, BUT DIFFICULTY SCREWING IN CAN YOU CONFIRM WHICH SUBSTANCE WAS BEING INFUSED AT THE TIME OF THE EVENT? SALINE SOLUTION CAN YOU CONFIRM WHETHER THE FAULT WAS IDENTIFIED DURING PRIMING OR INFUSION? IF DURING INFUSION, FOR HOW LONG? DURING INFUSION, 5MIN. CAN YOU CONFIRM THE DATE OF THE THIRD EVENT? WE HAVE THE 12/09 AND THE 27/09/24, COULD YOU PLEASE SPECIFY THE DATE OF THE 3RD EVENT? 1 EVENT ON 12/09 + 2 EVENTS ON 27/09.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541693 ↗MalfunctionOct 27, 2024Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION: CAN YOU CONFIRM THE INFUSION CONFIGURATION - GRAVITY OR PUMP, INFUSION LINE HEIGHT, PATIENT ENTRY POINT, INFUSION FLOW RATE AND PRESSURE, INFUSION LINE CONFIGURATION (OTHER EXTENSIONS OR ACCESSORIES), ETC.? NORMAL INFUSION LINE HEIGHT (ON PATIENT'S ARM). ENTRY POINT ON FOREARM. NO EXTENSIONS OR ACCESSORIES CAN YOU CONFIRM THE PRESENCE OF VISIBLE DAMAGE TO THE DEVICE, SUCH AS CRACKS, SPLINTERS OR DEFORMATION OF THE PLUNGER? NO VISIBLE DAMAGE, BUT DIFFICULTY SCREWING IN CAN YOU CONFIRM WHICH SUBSTANCE WAS BEING INFUSED AT THE TIME OF THE EVENT? SALINE SOLUTION CAN YOU CONFIRM WHETHER THE FAULT WAS IDENTIFIED DURING PRIMING OR INFUSION? IF DURING INFUSION, FOR HOW LONG? DURING INFUSION, 5MIN. CAN YOU CONFIRM THE DATE OF THE THIRD EVENT? WE HAVE THE 12/09 AND THE 27/09/24, COULD YOU PLEASE SPECIFY THE DATE OF THE 3RD EVENT? 1 EVENT ON 12/09 + 2 EVENTS ON 27/09.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541692 ↗MalfunctionSep 16, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233809 ↗MalfunctionSep 12, 2024Free or Unrestricted Flow; Free or Unrestricted Flow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201253 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.