MaxPlus MPX5300-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885403237218), received between Apr 2, 2019 and May 21, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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. Jun 16, 2026Open, Classified

   Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.

   Z-2941-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE CONNECTOR/STOPPER BECAME DETACHED DURING AGITATION OF SALINE OR CONTRAST DURING ECHO CARDIOGRAM WHICH CAUSED SALINE AND PATIENT BLOOD TO SPRAY ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247337 ↗
• MalfunctionJan 26, 2026Crack; Fluid/Blood Leak

  IT IS REPORTED COMPONENT CRACKED. DESCRIPTION: AFTER IV CATHETER WAS PLACED, THERE WAS AN ATTEMPT MADE TO CONNECT EXTENSION TUBING SET TO IV HUB. AFTER CONNECTING THE EXTENSION TUBING SET TO THE IV HUB, BLOOD LEAKED AT THE CLAVE WHEN PRIMED. UPON CLOSE INSPECTION A SLIGHT CRACK WAS NOTED ON THE CLAVE OF THE EXTENSION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177262 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YAKIMA IV THERAPY IS REPORTING AN IV EXT SET THAT CAME APART WHILE BEING FLUSHED. DEFECTIVE MPX5300-C. LOT#: 25059003. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENT OR SERIOUS INJURY WAS REPORTED. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? A NEW IV WAS PLACED. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO DELAY IN TREATMENT EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796646 ↗
• MalfunctionAug 19, 2025Leak/Splash; Leak/Splash

  PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843030 ↗
• MalfunctionApr 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING OUR CURRENT EXTENSION SETS HAVE THE SAME REFERENCE NUMBER: MPX5300-C, HOWEVER THE LOT NUMBERS ARE DIFFERENT, AND THE CONNECTION PORTS ARE DIFFERENT, LEAKING HAS BEEN REPORTED FROM MULTIPLE SOURCES (RADIOLOGY, ED, INPATIENT UNITS, CAIR LAB, PACU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752621 ↗
• MalfunctionApr 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM . OUR CURRENT EXTENSION SETS HAVE THE SAME REFERENCE NUMBER: MPX5300-C, HOWEVER THE LOT NUMBERS ARE DIFFERENT, AND THE CONNECTION PORTS ARE DIFFERENT, O LEAKING HAS BEEN REPORTED FROM MULTIPLE SOURCES (RADIOLOGY, ED, INPATIENT UNITS, CAIR LAB, PACU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752619 ↗
• MalfunctionApr 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM OUR CURRENT EXTENSION SETS HAVE THE SAME REFERENCE NUMBER: MPX5300-C, HOWEVER THE LOT NUMBERS ARE DIFFERENT, AND THE CONNECTION PORTS ARE DIFFERENT. LEAKING HAS BEEN REPORTED FROM MULTIPLE SOURCES (RADIOLOGY, ED, INPATIENT UNITS, CAIR LAB, PACU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752616 ↗
• MalfunctionMar 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE MAY BE SOME EXTENSION SETS THAT HAVE A HOLE IN THEM, LETTING BLOOD SPURT OUT AND AIR FLOW IN WHEN PLACED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580114 ↗
• MalfunctionNov 18, 2024Leak/Splash; Leak/Splash

  MATERIAL #: MPX5300-C AND BATCH#:24079542. IT WAS REPORTED BY CUSTOMER THAT THE TACOMA GENERAL ED SAID THE EXTENSION TUBING SETS CAME APART AT THE HUB. IT WAS THROWN AWAY AS IT WAS FULL OF BLOOD. VERBATIM: THE TACOMA GENERAL ED SAID THE EXTENSION TUBING SETS CAME APART AT THE HUB. IT WAS THROWN AWAY AS IT WAS FULL OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709117 ↗
• MalfunctionSep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL#: MPX 5300-C, BATCH#: 23129264, 24029513, 24019360. IT WAS REPORTED BY CUSTOMER THAT SPRIROS FALLS FROM MAXPLUS INJECTIONS SITE ON MPX5300-C. BD REP MET WITH CUSTOMER ON (B)(6). THERE HAVE BEEN 3 INSTANCES THE NURSING TEAM CAN RECALL: THE VIDEO ATTACHED IS FROM ON (B)(6) INCIDENT WHICH WAS YESTERDAY. LOT NUMBER POSSIBLE FOR EXTENSION MPX 5300-C, 23129264, 24029513, 24019360 IN THE OTHER 2 INSTANCES THE NURSES WERE ABLE TO ADMINISTER THE DOXORUBICIN (WHICH WAS RE-PREPARED BY PHARMACY), AT THE SAME PORT ON THE EXTENSION CLAVE. DUE TO THIS REASON, WE ARE ALSO REPORTING THIS TO THE ICU MEDICAL TEAM AS IT CAN POSSIBLY BE THE SPIROS CLAVE (NOT SURE THE BATCH) THESE INSTANCES OCCURRED IN THE ONCOLOGY CLINIC, AND THERE WERE NO INSTANCES REPORTED ON ANY IN-PT UNITS. SPRIROS FALLS FROM MAXPLUS INJECTIONS SITE ON MPX5300-C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141671 ↗
• MalfunctionMay 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE WHITE PART OF THE SMARTSITE INJECTION PORT IS CRACKED AND IT LEAKS WHEN FLUID IS ADMINISTERED. IT'S NOT EASILY VISIBLE AND REQUIRES SOME PRSSURE TO LEAK. SEE PICTURES AND VIDEOS ATTACHED. INICDENT OCCURED IN THE ICU TO ADMINISTER FENTANYL. IT,S THE SECOND SIMILAR INCIDENT IN THE ICU. THE FIRST ONE OCCURED IN FEBRUARY (PIR3077939) THE LOT NUMBER IS NOT AVAILABLE AND IT WAS NOT AVAILABLE FOR THE FIRT PIR EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402570 ↗
• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FLUSH WITH BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE LEAKAGE OCCURRED. SMALL DELAY IN PATIENT CARE. 2ND OF 2 REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO REPORT THREE INSTANCES OF INCIDENTS RELATED TO IV FLUSHES. TWO OF THESE INCIDENTS OCCURRED WHEN A NURSE WAS FLUSHING A PATIENT IV, AND THE THIRD INCIDENT TOOK PLACE IN RADIOLOGY WHERE THE IV WAS FLUSHED, BUT A LEAKAGE WAS NOTICED BY THE RADIOLOGY TECHNICIAN. FORTUNATELY, THESE INCIDENTS DID NOT HAVE ANY NEGATIVE IMPACT ON THE PATIENT'S OUTCOME, AND THE ONLY REQUIREMENT WAS THE REPLACEMENT OF THE IV EXTENSION. A PATIENT SAFETY REPORT HAS BEEN SUBMITTED TO ADDRESS THE POSSIBILITY OF IV-RELATED INJURIES. THE DELAY IN PATIENT CARE WAS MINIMAL, AND STAFF MEMBERS HAVE BEEN INFORMED TO CAREFULLY CHECK IV EXTENSIONS TO ENSURE THEY ARE NOT DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367742 ↗
• MalfunctionJun 23, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD MAXPLUS PRESSURE RATED EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTER "WE HAVE DISCOVERED A POTENTIAL DEFECT/ISSUE WITH THE BD MAXPLUS PRESSURE RATED EXTENSION SET (MPX5300-C). THE TUBING EASILY DETACHES IN TWO PLACES, AND DETACHED DURING A CT CONTRAST EXAM ON A PATIENT WHEN CONTRAST WAS ADMINISTERED. THIS RESULTED IN SPILLAGE OF BLOOD AND SOME CONTRAST MATERIAL. ALL IT TAKES IS A SLIGHT, GENTLE PULL AND THE TUBING DETACHES FROM BOTH SIDES OF THE CENTRAL CONNECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192965 ↗
• MalfunctionMay 15, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKE WHILE IN USE. DATE (B)(6) 2023 NO HARM REQUIRING TREATMENT, JUST SMALL AMOUNT OF BLOOD LOSS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934977 ↗
• MalfunctionMay 1, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE SEPARATED AT THE BONED JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILURE OF A BONDED JOINT ON THEIR EXTENSION SET. THE PRODUCT WHICH FAILED DURING PT CARE WAS NOT KEPT. HOWEVER, THE ASSISTANT NURSE MANAGER AT THE MWH ED STATED THAT OTHER UNITS HE ¿TESTED¿ HAVE ALSO COME APART RELATIVELY EASILY AT THE BONDED JOINT.".

  Patient problems: Exposure to Body Fluids

  MAUDE report 16850308 ↗
• MalfunctionJan 3, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 OF THE BD MAXPLUS¿ EXTENSION SET IS NOT ALLOWING US TO DRAW BLOOD OR FLUSH AN IV FROM EITHER PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS EXTENSION SET IS NOT ALLOWING US TO DRAW BLOOD OR FLUSH AN IV FROM EITHER PORT. THIS HAS HAPPENED ON 3 SEPARATE OCCASIONS, SO IT IS NOT CONSISTENT BUT IS AN ISSUE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16091355 ↗
• MalfunctionDec 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN HOOKING UP TO THE PATIENT) THE MALE CONNECTOR ON THE TPORT TO THE BLUNT TIP CANNULA, IT IS NOT A GOOD CONNECTION. BLOOD IS COMING OUT OF THE LOOSE CONNECTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057318 ↗
• MalfunctionDec 20, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT 14 BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS LOOSE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION FROM THE EXTENSION SET TO THE IV WILL CROSS THREAD AND LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018155 ↗
• MalfunctionOct 31, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD 9 IN EXTENSION SET W/MAX Y DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBING WAS FOUND TO BE DISCONNECTED UPON THE NURSE ENTERING THE ROOM. AT THE TIME THE IV WAS RUNNING AN INFUSION OF SEDATION MEDICATION AT THE TIME OF FAILURE." THE CUSTOMER DOES STILL HAVE THE CONTAMINATED DEVICE IN HER POSSESSION. PLEASE MAIL PROPER PACKAGING TO THE ATTENTION BELOW AND SHE WILL MAIL IT BACK FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700960 ↗
• MalfunctionSep 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD 9 IN EXTENSION SET W/MAX Y, THE DEVICE EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE EXTENSION SET SEPARATED AT THE MIDWAY JUNCTION WHICH RESULTED IN FREE FLOW BLOOD TO LEAVE THE PATIENT. THIS ALSO RESULTED IN THE PRIMARY TUBING TO ALLOW MEDICATION ONTO THE LINEN. UPDATE (B)(6) 2021: PERIPHERAL IV EXTENSION FOUND IN 2 PARTS. THESE 2 PIECES SEPARATED AT THE MID WAY JUNCTION. ONE HALF WAS CONNECTED TO THE PATIENT ALLOWING FREE FLOWING BLOOD TO LEAVE THE PATIENT. THE OTHER HALF WAS CONNECTED TO THE PRIMARY IV TUBING THUS ALLOWING IV MEDICATION TO FLOW ONTO THE LINEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547106 ↗
• MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING AT CONNECTION TO THE CATHETER. IT WAS NOTED HAT THE THREADS WERE NO THREADING ACCURATELY AND CRACKS WERE OBSERVED. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENT. "THIS FILE CAPTURES THE SEVERAL AND REPEATED ISSUES THAT WERE NOT REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106077 ↗
• MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING AT CONNECTION TO THE CATHETER. IT WAS NOTED HAT THE THREADS WERE NO THREADING ACCURATELY AND CRACKS WERE OBSERVED. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENT. "THIS FILE CAPTURES THE SEVERAL AND REPEATED ISSUES THAT WERE NOT REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106076 ↗
• MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING AT CONNECTION TO THE CATHETER. IT WAS NOTED HAT THE THREADS WERE NO THREADING ACCURATELY AND CRACKS WERE OBSERVED. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENT. "THIS FILE CAPTURES THE SEVERAL AND REPEATED ISSUES THAT WERE NOT REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106075 ↗
• MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING AT CONNECTION TO THE CATHETER. IT WAS NOTED HAT THE THREADS WERE NO THREADING ACCURATELY AND CRACKS WERE OBSERVED. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENT. "THIS FILE CAPTURES THE SEVERAL AND REPEATED ISSUES THAT WERE NOT REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106073 ↗
• MalfunctionJun 1, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING AT CONNECTION TO THE CATHETER. IT WAS NOTED HAT THE THREADS WERE NO THREADING ACCURATELY AND CRACKS WERE OBSERVED. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENT. "THIS FILE CAPTURES THE SEVERAL AND REPEATED ISSUES THAT WERE NOT REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106069 ↗