MaxZero MZ1000-07Recalls & reported problems
BD Switzerland Sàrl · Needleless Connector · Class 2
Quick summary
This BD MaxZero needleless connector, used on IV lines, appears in 627 adverse event reports, including 50 injuries and no deaths. Many reports describe fluid or blood leaking at the connection, caps sticking, and blockages. Reports rose to 94 in the last 12 months from 61 in the 12 months before. 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
- 622
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 622 adverse event reports that list this exact device (DI 10885403230196), received between May 8, 2018 and Sep 24, 2026 — classified as 50 injuries, 572 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (265 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
- Fluid/Blood Leak265
- Leak/Splash208
- Crack31
- Obstruction of Flow29
- Complete Blockage28
- Break19
- Failure to Disconnect19
- Disconnection18
Patient problems
- No Clinical Signs, Symptoms or Conditions242
- No Consequences Or Impact To Patient213
- No Information79
- No Known Impact Or Consequence To Patient37
- No Code Available20
- Insufficient Information12
- Low Blood Pressure/ Hypotension6
- Exposure to Body Fluids5
Recent adverse event reports
The 25 most recent of 622 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890863 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887545 ↗MalfunctionSep 3, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596719 ↗MalfunctionSep 3, 2026Failure to Disconnect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595924 ↗MalfunctionAug 31, 2026Disconnection; Leak/Splash; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533760 ↗MalfunctionAug 24, 2026Connection Problem
It was reported that the BD MaxZero Needleless Connector had connection issues.The following information was provided by the initial reporter: All three of patients caps stuck to line. This RN able to unstick one and complete cap change before requiring assistance from RN and the use of hemostats to remove other two caps from line. Primary caregiver removed first cap. 2nd Caregiver and hemostats aided for 2nd and 3rd cap. Patient stated that this has been a consistent issue. Event did reach patient. No evidence of patient harm/injury. Use of hemostats/tools increases risk of damage to fragile central line hubs. If damage continues, only option is for tunneled central line to be surgically replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50399550 ↗MalfunctionAug 17, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288151 ↗MalfunctionAug 16, 2026Failure to Disconnect
It was reported that BD maxzero needless connector had connection issues.the following information was received by the initial reporter with the following Verbatim.It was reported by the customer that they experienced difficulty removing the connector from the PICC line hub and observed a white film/residue on the PICC lumen hub.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266157 ↗MalfunctionJul 8, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754992 ↗MalfunctionJul 8, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754991 ↗MalfunctionJun 24, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS REPORTED ANOTHER CRACKED CONNECTOR FROM THEIR ON-GOING ISSUE. THIS CRACKED CONNECTOR HAPPENED ON (B)(6) 2026 AND IT OCCURRED AFTER METHOTREXATE, SODIUM BICARB WAS RUNNING AT 200ML/HR. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? MZ1000-07, NO LOT# PROVIDED. WHAT WAS THE IMPACT TO THE PATIENT? NO HARM DONE. PLEASE INDICATE APPROXIMATELY WHERE THE DEVICE WAS FRACTURED. NEAR SEPTUM ACCESS SURFACE. DID THE FRACTURE RESULT IN THE LOSS OF MEDICATION, AND/OR UNDERMEDICATION OF THE PATIENT? SODIUM BICARB WAS INFUSING. DID THE FRACTURE RESULT IN CONTACT WITH BODILY FLUIDS? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25613170 ↗MalfunctionJun 22, 2026Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAXZERO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578780 ↗MalfunctionJun 22, 2026Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAXZERO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578779 ↗MalfunctionJun 19, 2026Failure to Disconnect; Connection Problem
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE MAXZERO WITH VACUTAINER STUCK IN THE TOP OF THE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564915 ↗MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED THAT A BACTER MICRON FILTER BROKE OFF IN THE TOP OF THE MAXZERO CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490935 ↗MalfunctionJun 5, 2026Positioning Problem
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414751 ↗MalfunctionJun 5, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414542 ↗MalfunctionJun 5, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414539 ↗MalfunctionJun 5, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414519 ↗MalfunctionJun 5, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414475 ↗MalfunctionJun 5, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414269 ↗MalfunctionJun 4, 2026Break
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395112 ↗MalfunctionJun 4, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395111 ↗MalfunctionJun 4, 2026Break
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395110 ↗MalfunctionJun 4, 2026Crack
IT WAS REPORTED THAT BD MAXZERO NEEDLESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT 30 CRACKED LEAKING MAX ZERO MS10007 CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395106 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.