MaxGuard, MaxPlus MP9220-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885403237003), received between Oct 18, 2018 and May 29, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Crack; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKING FROM THE TRIFURCATE THAT WAS DIRECTLY CONNECTED TO THE PORT EXTENSION TUBING AND THAT THE HUB OF THE MALE CONNECTOR WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340961 ↗
• MalfunctionDec 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT FELT THE PART OF THE TRIFURCATE ATTACHED CRACK AND HAD TO USE A CLAMP TO DISCONNECT THE TRIFURCATE FROM THE CVC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918806 ↗
• MalfunctionDec 11, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT APPROXIMATELY 0800, THE RN ATTEMPTED TO DRAW FROM THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC). AFTER CLAMPING THE CVC, THE RN PROCEEDED TO DISCONNECT (TWIST OFF) THE TRIFURCATE THAT WAS ATTACHED TO THE PATIENT¿S TPN, LIPID INFUSION, AND HEPARIN DRIP. DURING THIS PROCESS, THE RN FELT THE TRIFURCATE CRACK AT THE POINT OF ATTACHMENT. TO DISCONNECT IT FROM THE CVC, A CLAMP WAS USED. THE RN THEN NOTIFIED THE CHARGE NURSE AND OBTAINED A NEW TRIFURCATE TO REATTACH, ENSURING CONTINUATION OF THE PATIENT¿S PN AND HEPARIN INFUSION. WAS PATIENT OR END-USER INJURED: UNK. WHEN WAS INCIDENT NOTICED: DURING USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: UNK. WAS THERE ANY LEAKAGE? YES, THERE WAS MEDICATION/SODIUM CHLORIDE ON MY BED SHEET. THIS IS NOT A NEW ISSUE - IT HAS BEEN GOING ON AND OFF FOR AT LEAST A YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778273 ↗
• MalfunctionDec 11, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT APPROXIMATELY 0800, THE RN ATTEMPTED TO DRAW FROM THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC). AFTER CLAMPING THE CVC, THE RN PROCEEDED TO DISCONNECT (TWIST OFF) THE TRIFURCATE THAT WAS ATTACHED TO THE PATIENT¿S TPN, LIPID INFUSION, AND HEPARIN DRIP. DURING THIS PROCESS, THE RN FELT THE TRIFURCATE CRACK AT THE POINT OF ATTACHMENT. TO DISCONNECT IT FROM THE CVC, A CLAMP WAS USED. THE RN THEN NOTIFIED THE CHARGE NURSE AND OBTAINED A NEW TRIFURCATE TO REATTACH, ENSURING CONTINUATION OF THE PATIENT¿S PN AND HEPARIN INFUSION. WAS PATIENT OR END-USER INJURED: UNK. WHEN WAS INCIDENT NOTICED: DURING USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: UNK. WAS THERE ANY LEAKAGE? YES THERE WAS MEDICATION/SODIUM CHLORIDE ON MY BED SHEET. THIS IS NOT A NEW ISSUE - IT HAS BEEN GOING ON AND OFF FOR AT LEAST A YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778271 ↗
• MalfunctionNov 18, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE RN WENT TO DISCONNECT A TRI-FUSE FROM THE MICROCLAVE, BLUE CAP, CONNECTED TO THE PIV, THE TRI-FUSE HUB BROKE OFF FROM THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23588788 ↗
• MalfunctionJul 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LEUER END OF THE BD MAXPLUS TRI-FUSE EXTENSION SET (REF MP-9220-C; LOT25019330) WAS CRACKED. THIS WAS REPLACED BY BD MAXZERO MICROBORE TRIFUSE EXTENSION SET (REF MZ9266 LOT (10)23129280). AT BLOOD DRAW ON [DATE REDACTED] THE NEXT DAY, THE LEUER END OF THIS EXTENSION SET WAS FOUND TO ALSO BE CRACKED. REPLACED THIS WITH THE BD MAXZERO MICROBORE BIFUSE EXTENSION SET (REF MZ9265 LOT 24119278). UNFORTUNATELY, THE CONNECTION STARTED LEAKING AS SOON AS THE IVF [INTRAVENOUS FLUIDS] AND NAHCO3 [SODIUM BICARBONATE] INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494174 ↗
• MalfunctionJun 11, 2025Defective Component; Incomplete or Inadequate Connection; Defective Component; Incomplete or Inadequate Connection

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189674 ↗
• MalfunctionJun 11, 2025Defective Component; Incomplete or Inadequate Connection; Defective Component; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT BD MAXGUARD MAXPLUS TRIFUSE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT BROKEN TRIFURCATE SET THAT WOULD NOT DISCONNECT FROM THE CAP. NURSING CHANGED THE CAPS AND TOOK OFF THE SET WITH THE CAP. HOWEVER, THE NEXT DAY WHEN DOING LABS, THE SAME SITUATION HAPPENED AND THEY HAD TO USE XXX CLAMPS TO DISCONNECT THE LEUR LOCK FROM THE CAP AND THEN CHANGE OUT THE ENTIRE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189673 ↗
• MalfunctionJan 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE ISSUES WERE RELATED TO LEAKING OR CRACKED MAX ZERO CAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263425 ↗
• MalfunctionJan 9, 2025Crack; Crack

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TRIFURCATE CRACKED WHEN I DISCONNECTED HER LINE TO CONNECT PATIENT TO BLOOD FOR TRANSFUSION. VERBATIM:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120812 ↗
• MalfunctionNov 27, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18212271 ↗
• MalfunctionOct 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 7-IN MINIBORE TRI-FUSE SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MP9220-C BATCH NO: 20035960 IT WAS REPORTED THAT THERE WAS A LEAKAGE WHERE THE TUBING CONNECTS TO THE CLAVE. EVENT DESCRIPTION PER EMAIL STATES: PRODUCT DESCRIPTION: TRI-FUSE EXT SET MANUFACTURER NAME: BD DAMAGE XLEAK BREAK WAS THERE AN INJURY OR DEATH? Y N IF YES, COMPLETE AN EPSO REPORT AND QUARANTINE EQUIPMENT ACCORDING TO POLICY GEN-015 DATE INCIDENT OCCURRED: (B)(6) 2020 IS PRODUCT QUARANTINED Y N EQUIPMENT: MED WATCH COMPLETED? Y (...) DETAILS OF ISSUE: LEAKING WHERE THE TUBING CONNECTS TO THE CLAVE, SOME ARE NOT CREATING A GOOD SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694560 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET LEAKED AT THE CONNECTION TO AN UNSPECIFIED MATING DEVICE. ALTHOUGH BLOOD AND IV FLUIDS LEAKED ONTO THE PATIENT'S CLOTHING, THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913455 ↗
• InjuryOct 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TRI-CONNECTOR USED TO CONNECT THE FLUIDS TO THE PICC APPEARED TO HAVE LEAKED WHICH PREVENTED THE FLUIDS FROM RUNNING THROUGH THE TUBING PROPERLY. THE CLINICIAN CHANGED THE CONNECTOR RESULTING IN NO FURTHER COMPLICATIONS. A HCT WAS PERFORMED AND WAS WITHIN NORMAL LIMITS. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981132 ↗