MaxGuard MX9433Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885403237782), received between Jun 3, 2021 and Mar 16, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1760-2022 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608073 ↗
• MalfunctionJan 15, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087056 ↗
• MalfunctionJan 15, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086246 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT TUBING CAME APART INTO TWO PIECES AT THE LOWEST PORT WHEN THEY TRIED TO PULL THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455120 ↗
• MalfunctionJul 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE WAS DAMAGEDTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: TUBING BROKE OFF FROM BELOW THE PORT WHEN MEDICATIONS WERE INJECTED. ANESTHESIOLOGIST WENT TO INJECT PROPOFOL THROUGH THE LINE AND THE TUBING WAS LEAKING AND DID NOT STAY CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806463 ↗
• MalfunctionJul 20, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESSY-SITE(S) THE LUER LOCK WOULD NOT ATTACH AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT INFORMATION OR IMPACT. THIS IS THE 1ST OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STARTED AN IV. WENT TO ATTACH THE TUBING TO START THE LR AND THE LURE LOCK WOULD NOT ATTACH AND LR LEAKED EVERYWHERE. HAD TO GET NEW TUBING AND PRIME A WHOLE NEW LINE. THIS HAS HAPPENED NOW TWO TIMES WITH THE SAME PROBLEM. NEEDS TO BE FIXED.

  Patient problems: Insufficient Information

  MAUDE report 17358095 ↗
• MalfunctionJul 14, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) THERE WAS COMPONENT SEPARATION AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: STARTED AN IV. WENT TO ATTACH THE TUBING TO START THE LR AND THE LURE LOCK WOULD NOT ATTACH AND LR LEAKED EVERYWHERE. HAD TO GET NEW TUBING AND PRIME A WHOLE NEW LINE. WHILE THIS WAS GOING ON THE PATIENT WAS NAUSEOUS AND ABOUT TO PASS OUT FROM EVERYTHING THAT WAS HAPPENING. PATIENT WAS VERY UNCOMFORTABLE AND DISCONCERTING TO THE PATIENT. THIS HAS HAPPENED NOW TWO TIMES WITH THE SAME PROBLEM. NEEDS TO BE FIXED. BACKGROUND: EVENT DATE: (B)(6) 2023 IH #: 32011614 MFG #: MX9433 DESCRIPTION: SET ADMIN IV 130IN 15DROP SAMPLE AVAILABLE : Y/N (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 23029244 ASSESSMENT: WAS THERE INJURY? NO - ARE YOU ABLE TO PROVIDE THE PATIENT IDENTIFIERS (NAME, AGE, DATE OF BIRTH, ETC.) IF AVAILABLE. MALE, 35 YO - WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS.

  Patient problems: Discomfort; Dizziness

  MAUDE report 17330444 ↗
• MalfunctionMay 12, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE HAD NO END ON THE TUBING TO CONNECT IT TO THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "D IV TUBING WAS FLAWED. ON OPENING IV TUBING IT WAS NOTED THAT THERE WAS NO END ON THE TUBING TO CONNECT IT TO THE IV START TUBING THAT WOULD BE USED ON THE PT. NEW TUBING SET WAS OBTAINED TO ATTACH TO IV BAG. PT NOT AWARE THAT THERE WAS ANY ISSUE WITH THE IV TUBING AND NOT INVOLVED BECAUSE IT WAS DISCOVERED BEFORE THE IV WAS STARTED. WAS THERE ONLY ONE OCCURRENCE OF THIS ISSUE? YES ¿ SO FAR WE HAVE ONLY HEARD OF IT HAPPENING ONCE. WAS THERE ANY PATIENT HARM OR ADVERSE OR ADVERSE EVENTS? NO PATIENT HARM. ISSUE WAS DISCOVERED BEFORE IT EVER REACHED A PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920263 ↗
• MalfunctionApr 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED COMPONENT SEPARATION. THIS IS 3 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿DURING TX FROM OR TABLE TO GURNEY IV TUBING CAUGHT AND DISCONNECTED WHERE TUBING CONNECTS TO THE 4TH NEEDLELESS Y-SITE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812540 ↗
• MalfunctionApr 25, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED FLOW ISSUE. THIS IS 1 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IV TUBING SETS, ONE WOULD NOT SCREW ONTO THE IV TUBE THE OTHER WOULD NOT DRIP ANYTHING¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812539 ↗
• MalfunctionApr 25, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THIS IS 2 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿PRIMED THE IV TUBING. PRIMED NORMALLY. DID THE IV. WHEN I CONNECTED THE IV AND OPENED THE FLUID LINE, THE FLUID AND BLOOD STARTING GOING EVERYWHERE DUE TO THE MEDICATION PORT NOT ATTACHED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812538 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) COMPONENTS SEPARATED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING ANOTHER REPORT ON ITEM 32011614 SET ADMIN IV 130IN 15DROP 4PORT 50/CA BEING DEFECTIVE. ONE OF OUR FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. SITUATION: ISSUE: PRIMED THE IV TUBING. PRIMED NORMALLY. DID THE IV. WHEN I CONNECTED THE IV AND OPENED THE FLUID LINE, THE FLUID AND BLOOD STARTING GOING EVERYWHERE DUE TO THE MEDICATION PORT NOT ATTACHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624709 ↗
• MalfunctionMar 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED TUBING COMING APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: MULTIPLE REPORTS OF TUBING COMING APART AT PORT/DRIP CHAMBER. TWO LOTS HAVE BEEN IDENTIFIED WITH THE ISSUE AND HAVE BEEN SEEN AT MULTIPLE FACILITIES. SO FAR WE HAVE CONFIRMED REPORTS AT (B)(6) HOSPITAL AND (B)(6). EVENT DATE: (B)(6) 2023. IH #: (B)(4). MFG #: MX9433. DESCRIPTION: SET ADMIN IV 130IN 15 DROP. SAMPLE AVAILABLE : Y (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 22119051 AND 22099088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527245 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE COMPONENTS WERE SEPARATING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: MULTIPLE REPORTS OF TUBING COMING APART AT PORT/DRIP CHAMBER. TWO LOTS HAVE BEEN IDENTIFIED WITH THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517872 ↗
• MalfunctionJun 3, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 130 IN 15 DROP IV ADMIN SET W/4 HAD FLOW ISSUES. THIS OCCURRED ON 1172 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE MEDICATION FLOWS DOWN TOWARD THE PATIENT INSTEAD OF GOING UPSTREAM INTO THE DRIP CHAMBER WHILE THE IV IS RUNNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931345 ↗