MaxPlus MP1000-CRecalls & reported problems
BD Switzerland Sàrl · Clear Needleless Connector · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD MaxPlus needleless connector appears in 265 adverse event reports, with no deaths and 1 injury. The reports mostly describe fluid or blood leaking at the connection, connectors that stick when activated, and parts that crack, separate or break. Reports fell to 14 in the last 12 months from 25 in the year before. One recall, from May 2019 and now closed, concerns a valve that may stay partly open after disconnection, which could lead to blood loss or air entering the bloodstream.
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
- 265
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 10885403223228), received between Sep 11, 2018 and Sep 22, 2026 — classified as 1 injury, 264 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (105 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- May 2, 2019Terminated
After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
Z-0049-2020 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak105
- Physical Resistance/Sticking85
- Leak/Splash51
- Activation Failure27
- Break7
- Insufficient Device Problem Information7
- Device Contamination with Chemical or Other Material4
- Obstruction of Flow4
Patient problems
- No Consequences Or Impact To Patient138
- No Information61
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient15
- Insufficient Information4
- Hemolysis1
Recent adverse event reports
The 25 most recent of 265 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Crack; Leak/Splash
It was reported, MaxPlus, crack, causing leak.The following was provided by the initial reporter: A crack formed at the connection between the needle-free connector and the infusion set during an IV infusion, causing fluid leakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854718 ↗MalfunctionSep 17, 2026Leak/Splash
It was reported, Maxplus, leak during use.The following was provided by the initial reporter: During use, fluid leakage was discovered at the connection point of the central venous catheter; 10 units were found to be defective.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802835 ↗MalfunctionFeb 27, 2026Disconnection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466122 ↗MalfunctionFeb 12, 2026Disconnection
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319836 ↗MalfunctionJan 27, 2026Disconnection; Leak/Splash
IT IS REPORTED SEPARATION. DESCRIPTION: THE SPIROS CONNECTOR DETACHED OR UNSCREWED FROM THE BD PRODUCT (LOT #25085772) DURING LONG INFUSIONS. LEAKAGE: CHEMOTHERAPY LIQUID WAS LEFT ON THE OUTSIDE/TOP OF THE CONNECTOR AND DRIPPED, WHICH COULD POSE CONTAMINATION AND EXPOSURE RISKS.
Patient problems: Insufficient Information
MAUDE report 24189688 ↗MalfunctionJan 9, 2026Material Disintegration
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE SPIRAL CONNECTOR DISENGAGED FROM THE BD NEEDLESS CONNECTOR, THIS CAUSED A LEAKAGE AND COULD HAVE LEAD TO CHEMO EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24024215 ↗MalfunctionDec 17, 2025Crack; Crack
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE FOUR-WAY QUAD FUSE CRACKED AT CONNECTION TO IV LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835157 ↗MalfunctionDec 16, 2025Break; Break
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS BROKE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE END OF IV TUBING BROKE OFF AND STUCK IN BLUE CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824847 ↗MalfunctionDec 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY NOTED THAT THE BLINATUMOMAB INFUSION WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824839 ↗MalfunctionDec 16, 2025Break; Break
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WHILE DISCONNECTING HEPARIN LINE FROM PIV, THE NECK PORTION OF THE LINE BROKE OFF INTO THE IV HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824838 ↗MalfunctionNov 14, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23558815 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557079 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557075 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557074 ↗MalfunctionOct 31, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MalfunctionOct 30, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT QUADFUSE IV CONNECTION PLASTIC LUER LOCK FELL OFF CAUSING THE QUADFUSE WITH MEDS TO BECOME DISCONNECTED FROM THE PATIENT IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433372 ↗MalfunctionOct 29, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT THE BD MAXPLUS NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUADFUSE IV CONNECTION PLASTIC LUER LOCK FELL OFF CAUSING THE QUADFUSE WITH MEDS TO BECOME DISCONNECTED FROM THE PATIENT IV. THIS HAS HAPPENED A FEW TIMES RECENTLY. INJURIES OR ADVERSE EVENT: NO, ITEM: MP1000-C, QUANTITY AFFECTED: 2 EA, SERIAL/LOT NUMBER: N/A. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE LOT NUMBER WAS UNKNOWN. TO MY KNOWLEDGE, THIS HAPPENED TWICE. HARM LEVEL: NONE TO PATIENT OR NURSE. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IT WAS NOT CHEMO. IT WAS LIKELY SEDATION AND IV FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416414 ↗MalfunctionOct 29, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT THE BD MAXPLUS NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUADFUSE IV CONNECTION PLASTIC LUER LOCK FELL OFF CAUSING THE QUADFUSE WITH MEDS TO BECOME DISCONNECTED FROM THE PATIENT IV. THIS HAS HAPPENED A FEW TIMES RECENTLY. INJURIES OR ADVERSE EVENT: NO ITEM: MP1000-C QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: . ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE LOT NUMBER WAS UNKNOWN. TO MY KNOWLEDGE, THIS HAPPENED TWICE. HARM LEVEL: NONE TO PATIENT OR NURSE. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IT WAS NOT CHEMO. IT WAS LIKELY SEDATION AND IV FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416397 ↗MalfunctionAug 19, 2025Leak/Splash; Leak/Splash
MalfunctionAug 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAVE RECENTLY NOTED AN INCREASINGLY COMMON DEFECT IN THE BD MP1000-C MAXPLUS CLEAR NEEDLESS CONNECTOR. ACCORDING TO STAFF REPORTS, THE DEVICE LEAKS AT ITS SEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836180 ↗MalfunctionAug 13, 2025Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE BD MAXPLUS NEEDLELESS CONNECTOR WAS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAXPLUS COULD NOT BE REMOVED FROM CATHETER HUB, HAD TO BE REMOVED WITH FORCEPS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE SHARE THE LOT# NUMBER IF AVAILABLE. WE WERE UNABLE TO IDENTIFY LOT NUMBER DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT INJURY OR HARM, BUT NEEDLELESS CONNECTOR NEEDED TO BE REMOVED WITH FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22800378 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT AFTER PLACING THEY NOTICED THAT IT WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777210 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER PLACING THEY NOTICED THAT IT WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22776450 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER PLACING THEY NOTICED THAT IT WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22776444 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS NEEDLESS CONNECTOR. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER PLACING THEY NOTICED THAT IT WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22776420 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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