MaxPlus MPX5302-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, with removable needleless connector and Y-site 23 cm (9 in) · Class 2
Quick summary
This BD MaxPlus extension set is pressure-rated IV tubing with a needleless connector. The 24 reports that name its identifier describe leaking and parts separating or coming loose at the Y-site connection, with no deaths and no injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885403237232), received between Aug 10, 2018 and Feb 10, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 Leak12
- Material Separation4
- Leak/Splash3
- Loose or Intermittent Connection2
- Break1
- Complete Blockage1
- Component Missing1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient4
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Fluid/Blood Leak; Material Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304574 ↗MalfunctionFeb 9, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24294031 ↗MalfunctionMay 29, 2025Break; Separation Failure; Break; Separation Failure
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109370 ↗MalfunctionAug 8, 2024Leak/Splash; Leak/Splash
MATERIAL: MPX5302-C BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT ITEM IMEMPX5302C IS LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ITEM: MPX5302-C QUANTITY AFFECTED:2EA SERIAL/LOT NUMBER:UNK PO : 4517509137 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: CUSTOMER XXXX EMAILED STATING THAT ITEM IMEMPX5302C IS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19940754 ↗MalfunctionApr 26, 2024Defective Component; Defective Component
MATERIAL#: MPX5302-C. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE SIDE PORT OF THE EXTENSION SET OOZES BLOOD WHILE FLUSHING. I TAKE IT THAT SHE IS HOOKING A VACUTAINER TO THE SIDE, PROXIMAL PORT AND DRAWING BLOOD AND THEN FLUSHING THE DISTAL PORT WITH SALINE. I DON'T KNOW IF THIS PROCESS IS DAMAGING THE INTERNAL VALVE ON THE PROX. SIDE PORT AND CAUSING THE ISSUE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GOOD MORNING CHRISTINE. ONE OF OUR TEAMMATES HAS REPORTED THAT THE SIDE PORT OF THE EXTENSION SET OOZES BLOOD WHILE FLUSHING. I TAKE IT THAT SHE IS HOOKING A VACUTAINER TO THE SIDE, PROXIMAL PORT AND DRAWING BLOOD AND THEN FLUSHING THE DISTAL PORT WITH SALINE. I DON'T KNOW IF THIS PROCESS IS DAMAGING THE INTERNAL VALVE ON THE PROX. SIDE PORT AND CAUSING THE ISSUE. DO YOU HAVE ANY GUIDANCE ON THIS ISSUE OR CAN PUT ME IN CONTACT WITH THE REP WHO HANDLES THIS DEVICE? THANK YOU! MD MAX PLUS EXT SET MPX5302-C.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198335 ↗MalfunctionAug 8, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE EXTENSION TUBING FELL APART AT THE Y-SITE CONNECTION AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT'S IV EXTENSION TUBING FELL APART AT THE Y-SITE CONNECTION.
Patient problems: Insufficient Information
MAUDE report 17481189 ↗MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEPARATING AT THE Y SITE, THEY BLOW APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820704 ↗MalfunctionApr 26, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE ARE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALSO, THE LARGEST END ON SOME ARE COMING IN VERY LOOSE, NOT WELL CONNECTED AND JUST FALL TO THE FLOOR DURING USE AND THEN THE EXTENSION SET HAS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820700 ↗MalfunctionMar 30, 2023Component Missing; Component Missing
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD MAXPLUS¿ PRESSURE RATED EXTENSION SES WITH NEEDLELESS CONNECTOR AND Y-SITE WERE MISSING THEIR HUBS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD MAX PLUS EXTENSION SET ITEM#I MEMPX5302C ARE PACKAGED WITH THE HUBS EITHER MISSING ENTIRELY OR EXTREMELY LOOSE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16653055 ↗MalfunctionMar 24, 2023Material Separation; Material Separation
IT WAS REPORTED WHILE USING BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION SET IS BLOWING APART WHERE THE TUBING MEETS THE CONNECTORS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16612602 ↗MalfunctionMar 14, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE SEPARATED AT THE CONNECTION OF THE TUBING AND CONNECTOR. THIS OCCURRED WITH 1 SET EACH FROM LOTS 22109034 AND 22109036 DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EXTENSION SET IS BLOWING APART WHERE THE TUBING MEETS THE CONNECTORS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16538256 ↗MalfunctionJan 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 BD MAXPLUS¿ PRESSURE RATED EXTENSION SETS WITH NEEDLELESS CONNECTOR AND Y-SITE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAK".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200110 ↗MalfunctionOct 24, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 BD MAXPLUS¿ PRESSURE RATED EXTENSION SETS WITH NEEDLELESS CONNECTOR AND Y-SITE HAD CLOGGED TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID DOES NOT FLOW THROUGH TUBING. HAS HAPPENED AT LEAST TWO TIMES WITH DIFFERENT STAFF WITH THE SAME LOT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663327 ↗MalfunctionMar 25, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BLOOD LEAKED FROM THE EXTENSION TUBING SET WHILE IN USE ON AN ADULT PATIENT. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9877190 ↗MalfunctionOct 2, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAK OCCURRED DURING PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7928620 ↗MalfunctionOct 2, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAK OCCURRED DURING PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7928514 ↗MalfunctionSep 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CAP LEAKS WHEN IV WAS HOOKED UP. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7866881 ↗MalfunctionSep 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CAP LEAKS WHEN IV WAS HOOKED UP. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7866723 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774782 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774778 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774719 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774665 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774271 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY USE THE EXTENSION SET ON LABORING PATIENTS WHO ARE RECEIVING PITOCIN TO STRENGTHEN LABOR CONTRACTIONS DURING CHILDBIRTH. THE EXTENSION TUBING SET HAS BEEN FOUND TO BE LEAKING IV FLUIDS OR BLOOD FROM THE NAC-Y NEEDLE-FREE VALVE THAT IS LOCATED 4 INCHES FROM THE SPIN MALE LUER LOCK. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774230 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.