BD MaxPlusRecalls & reported problems across all models

We found 9 models of BD MaxPlus by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2019 and Mar 9, 2023 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BD MaxPlus problems

BD MaxPlus models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD MaxPlus MPX9102-C

  Set, administration, intravascular
  22 reports
• BD MaxPlus MP9229

  Set, administration, intravascular
  4 reports
• BD MaxPlus MP9213-C

  Set, administration, intravascular
  3 reports
• BD MaxPlus MP9001-C

  Set, administration, intravascular
  2 reports
• BD MaxPlus MP9027-C

  Set, administration, intravascular
  1 report
• BD MaxPlus MP9081-C

  Set, administration, intravascular
  1 report
• BD MaxPlus MP9232-C

  Set, administration, intravascular
  1 report
• BD MaxPlus MPX9101-C

  Set, administration, intravascular
  1 report
• BD MaxPlus MPX9105-C

  Set, administration, intravascular
  1 report

Recent BD MaxPlus adverse event reports

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

• MalfunctionMar 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OMITTED STATE THAT BY THE PORT THE LOWER LOCK IS COMING OFF AND THE PATIENT IS NOT GET THEIR MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519225 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS¿ EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE DISCONNECTED AT THE CONNECTION POINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SIN 82991 MPX9101-C EXTENSION SET FOUND DISCONNECTED AT POINT NOT FOR CONNECTION. NO INCIDENT OF TUGGING, PULLING OR CATCHING ON ANYTHING IDENTIFIED. PATIENT NOT CLINICALLY ABLE TO BREAK/DISCONNECT LINE AT POINT OF DISCONNECTION.."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118388 ↗
• MalfunctionDec 7, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS¿ NEEDLE-FREE CONNECTOR WAS CRACKED AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE CHANGING OUT SET AND AFTER ALL INFUSIONS WERE RESTARTED FOR ABOUT 5 MINUTES, PATIENT C/O FEELING LEAKAGE OF FLUID FROM IV SITE. RN ASSESSED AND NOTICED THE MAX-PLUS CONNECTOR WAS CRACKED IN SEVERAL PIECES. RN REMOVED THE CONNECTOR AND AS SHE WAS GETTING READY TO CHANGE OUT, SHE NOTICED A BACKFLOW OF BLOOD COMING OUT OF THE Y-SITE BACK CHECK VALVE ON THE MAINLINE AND A POOL OF BLOOD ON LINEN. IV LINE IMMEDIATELY DC'D AND SWITCHED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936620 ↗
• MalfunctionMar 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT SHE HAS HAD ISSUES WITH THE EXTENSION TUBING SEPARATING FROM THE IV CATHETER IN THE VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690655 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE 8 IN KINK RESISTANT SET W/MAXPLUS EXPERIENCED RUPTURED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALES REP HAS A CUSTOMER THAT INFORMED HIM THAT THE MAXPLUS EXTENSION SET MP9081-C IS BURSTING AROUND 250 PSI. SAYS PACKAGING SAYS BURST RATE IS AROUND 325 PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136924 ↗
• MalfunctionJul 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF MAXGUARD MULTI-FUSE EXTENSION SETS WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS IN CT WITH A PATIENT WHO NEEDED CONTRAST AND HAD TO BE MONITORED. THE CT ALARMED AFTER A FEW MINUTES WITH AN OCCLUSION. WHEN WE WENT TO INVESTIGATE AND THE J-LOOP HAD SPLIT WITH BLOOD AND CONTRAST LEAKING EVERYWHERE MAKING IT VERY DIFFICULT TO FIX. I DON'T KNOW IF IT WAS DUE TO THE CONTRAST OR IF IT WAS JUST A FLUKE BUT THIS IS THE FIRST TIME I'VE SEEN THIS HAPPEN SINCE USING THEM. AFTER SPEAKING WITH THE TEAM LEADER HE SAID IT WAS THE ACTUAL TUBING WAS SPLIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305828 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 7 IN MINIBORE EXTENSION SET W/MAXPLUS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS WAS AGAIN REPORTED BY A NURSE IN OUR (B)(6) CLINIC. SHE REPORTS THAT WHEN SHE TRIED TO FLUSH THE BD MAXPLUS EXTENSION SET IT BEGAN LEAKING FROM THE NEEDLELESS CONNECTOR WHERE IT MEETS THE TUBING. THE REF NUMBER IS MP9001-C AND THE LOT NUMBER IS (10) 20036418. CUSTOMER RESPONSE (B)(6) 2020: THE INCIDENT TOOK PLACE ON (B)(6) 2020, I AM NOT SURE OF THE EXACT TIME. THE NURSE STATES THAT THE EXTENSION TUBING WAS INITIALLY PRIMED WITH NO ISSUE, BUT ONCE ATTACHED TO THE PATIENT BEGAN LEAKING WHEN FLUSHED WITH FLUID AT THE SITE WHERE THE NEEDLELESS CONNECTOR ATTACHES TO THE TUBING. THERE WAS NO HARM TO THE PATIENT AND THE NURSE DISCARDED THE EXTENSION SET AS IT WAS THEN CONTAMINATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272981 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT EXTENSION SETS CAME APART. LAST WEEK WE HAD THE SAME PROBLEM, THE 14' EXTENSION SET WAS SHOOTING OFF THE SYRINGES.

  Patient problems: No Information

  MAUDE report 9123289 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT EXTENSION SETS CAME APART. THE CUSTOMER STATED THAT THE 7" SETS BROKE APART WHILE BEING USED BY A DIFFERENT NURSE WHILE IN THE FIELD SEEING A PATIENT.

  Patient problems: No Information

  MAUDE report 9123286 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT EXTENSION SETS CAME APART. THE FUSED END SHOT ACROSS THE ROOM WHILE BEING USED IN THE INFUSION SUITES. NOBODY WAS HURT BUT THEY WERE CONCERNED ABOUT THIS HAPPENING.

  Patient problems: No Information

  MAUDE report 9120863 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT EXTENSION SETS CAME APART. THE FUSED END SHOT ACROSS THE ROOM WHILE BEING USED IN THE INFUSION SUITES. NOBODY WAS HURT BUT THEY WERE CONCERNED ABOUT THIS HAPPENING.

  Patient problems: No Information

  MAUDE report 9120861 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MAXPLUS EXTENSION SET LEAKED IN THE ER. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786221 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MAXPLUS EXTENSION SET LEAKED IN THE ER. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785954 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MAXPLUS EXTENSION SET LEAKED IN THE ER. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785948 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MAXPLUS EXTENSION SET LEAKED IN THE ER. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785883 ↗

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