MaxPlus MP5303-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 10885403236655), received between Feb 20, 2019 and May 28, 2026 — classified as 4 injuries, 163 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (64 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY IV TUBING BECAME DISCONNECTED FROM IV EXTENSION SET AND IV FLUID LEAKED ALL OVER THE STRETCHER AND ONTO THE PATIENT GOWN AND BEDDING. THIS IS THE SECOND TIME I HAVE SEEN THIS HAPPEN WITH THIS TYPE OF IV EXTENSION SET WHERE THE PRIMARY IV BECOMES ACCIDENTALLY DISCONNECTED. PRODUCT NAME AND/OR CATALOG NUMBER: BD MAX PLUS PRESSURE. LOT NUMBER OR SERIAL NUMBER: N/A ANY INJURIES AND/OR HARM? NO IV EXTENSION SET IS AS FOLLOWS: BD MAX PLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320001 ↗
• MalfunctionMay 28, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY IV TUBING BECAME DISCONNECTED FROM IV EXTENSION SET AND IV FLUID LEAKED ALL OVER THE STRETCHER AND ONTO THE PATIENT GOWN AND BEDDING. THIS IS THE SECOND TIME I HAVE SEEN THIS HAPPEN WITH THIS TYPE OF IV EXTENSION SET WHERE THE PRIMARY IV BECOMES ACCIDENTALLY DISCONNECTED. PRODUCT NAME AND/OR CATALOG NUMBER: BD MAX PLUS PRESSURE LOT NUMBER OR SERIAL NUMBER: N/A ANY INJURIES AND/OR HARM? NO IV EXTENSION SET IS AS FOLLOWS: BD MAX PLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319997 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED, MAX PLUS CONNECTOR WAS NOT SECURELY ON THE EXTENSION SET, CONNECTED TO THE IV HUB IT SPURTED BLOOD.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24940414 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED, MAX PLUS CONNECTOR WAS NOT SECURELY ON THE EXTENSION SET, CONNECTED TO THE IV HUB IT SPURTED BLOOD.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24940411 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED, MAX PLUS CONNECTOR WAS NOT SECURELY ON THE EXTENSION SET, CONNECTED TO THE IV HUB IT SPURTED BLOOD.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24940409 ↗
• MalfunctionMar 13, 2026Nonstandard Device

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS DAMAGED DEFECTIVE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT DEFECTIVE ITEM-EXTENSION SET¿S BLUE CAP FELL OFF WHEN RN WENT TO FLUSH ANGIOCATH (CLEARLY NOT TIGHTENED PRIOR TO PACKAGING). EXTENSION SET ALSO UNABLE TO TIGHTEN ONTO ANGIOCATH. AND EXTENSION SET CLAMP WAS UNABLE TO BE CLAMPED BY RN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598295 ↗
• MalfunctionMar 13, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUESTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY THE CUSTOMER THAT DEFECTIVE ITEM-EXTENSION SET¿S BLUE CAP FELL OFF WHEN RN WENT TO FLUSH ANGIOCATH (CLEARLY NOT TIGHTENED PRIOR TO PACKAGING). EXTENSION SET ALSO UNABLE TO TIGHTEN ONTO ANGIOCATH. AND EXTENSION SET CLAMP WAS UNABLE TO BE CLAMPED BY RN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591692 ↗
• MalfunctionMar 11, 2026Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573109 ↗
• InjuryMar 11, 2026

  AFTER SEVERAL HOURS OF MILD, IRREGULAR CONTRACTIONS, THE MIDWIFE, PATIENT, AND SUPPORT PERSON DISCUSSED OPTIONS AND JOINTLY DECIDED TO BEGIN AN OXYTOCIN INFUSION TO HELP STRENGTHEN THE LABOR PATTERN. OXYTOCIN WAS INITIATED ACCORDING TO POLICY. SHORTLY AFTER OXYTOCIN WAS INITIATED AT 2 ML/HR, THE IV PUMP ALARMED FOR "AIR IN LINE." THE NURSE CLAMPED THE IV TUBING AT THE SALINE LOCK EXTENSION AND USED A SYRINGE TO REMOVE THE AIR. AT 22:21, THE NURSE OBSERVED THAT THE OXYTOCIN WAS INADVERTENTLY INFUSING BY GRAVITY, RESULTING IN AN UNINTENDED BOLUS. THE CLAMP HAD NOT FULLY OCCLUDED THE LINE. OXYTOCIN WAS IMMEDIATELY DISCONNECTED. AT 22:23, THE PATIENT EXPERIENCED A TETANIC CONTRACTION ACCOMPANIED BY A PROLONGED FETAL HEART RATE DECELERATION. THE NURSE PROMPTLY CALLED FOR ADDITIONAL ASSISTANCE AND NOTIFIED THE CNM [CERTIFIED NURSE MIDWIFE]. INTRAUTERINE RESUSCITATION MEASURES-INCLUDING IV FLUID BOLUS, MATERNAL REPOSITIONING, AND ADMINISTRATION OF TERBUTALINE-WERE INITIATED IMMEDIATELY. THE OBSTETRICIAN ARRIVED AT 22:28. CERVICAL EXAMINATION REVEALED 5 CM DILATION. AS THE PATIENT WAS REMOTE FROM DELIVERY, THE TEAM PROCEEDED TO THE OPERATING ROOM FOR A STAT CESAREAN SECTION. AT 22:35 IN TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fetal Distress

  MAUDE report 24567873 ↗
• MalfunctionMar 5, 2026Failure to Disconnect; Connection Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524982 ↗
• MalfunctionMar 3, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500987 ↗
• MalfunctionFeb 6, 2026Connection Problem

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LEAKING OCCURRED WHERE THE J LOOP CONNECTS TO THE IV CATHETER/HUB, A 18-GAUGE IV CATHETER WAS USED. THE IV WAS TESTED WITH A 10CC SALINE HAND FLUSH, NO LEAKING OCCURRED. LEAKING WAS NOTICED ABOUT 5 SECONDS AFTER THE POWER INJECTION BEGAN. INJECTION WAS PAUSED, CHANGED OUT THE J-LOOP, AND CONTINUED THE INJECTION WITH NO ISSUES. PATIENT CAME FROM ED. WE DO NOT KNOW IF THE IV WAS PLACED BY EMS, THE ED STAFF WOULD EXCHANGE THE EMS TUBING FOR THE J LOOP. IMPACT TO PATIENT: NO HARM. HIGH LEVEL OF CONCERN WITH LEAKING CONTRAST ON PATIENTS ARM, FROM HIGH PRESSURE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275718 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Extravasation

  MAUDE report 24238154 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  NO ADDITIONAL INFORMATION

  Patient problems: Extravasation

  MAUDE report 24238112 ↗
• MalfunctionJan 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM HIGH LEVEL OF CONCERN ABOUT LEAKING CONTRAST ON ARM, NO HARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121726 ↗
• MalfunctionJan 14, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT ANOTHER MP5303-C AT AMC-SUMMIT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE IMPACT TO THE PATIENT? HIGH LEVEL OF CONCERN ABOUT LEAKING CONTRAST ON ARM, NO HARD. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE LEAKING OCCURRED WHERE THE J LOOP CONNECTS TO THE IV CATHETER/HUB. THE IV WAS TESTED WITH A 10CC SALINE HAND FLUSH, NO LEAKING OCCURRED. LEAKING WAS NOTICED ABOUT 5 SECONDS AFTER THE POWER INJECTION BEGAN. I PAUSED THE INJECTION, CHANGED OUT THE J-LOOP, AND CONTINUED THE INJECTION WITH NO ISSUES. WE DO NOT KNOW THAT EVEN IF THE IV WAS PLACED BY EMS, THE ED STAFF WOULD EXCHANGE THE EMS TUBING FOR THE J LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071619 ↗
• MalfunctionJan 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CATHETER (20 GAUGE) LEAKED DURING CT INJECTION, 4.5 ML/SEC. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORT? UNAVAILABLE, WE HAVE SAVED THE PRODUCT HOWEVER. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM. IV CATHETER (20 GAUGE) LEAKED DURING CT INJECTION, 4.5 ML/SEC. PATIENT RE-INJECTED. PLEASE CLARIFY THE LOCATION OF THE REPORTED LEAK. DID IT OCCUR AT THE CLAMPING POSITION OR AT ONE OF THE ADAPTER JUNCTIONS? OCCURRED ON END CONNECTED TO IV CATHETER, SAME AS OTHER REPORTED OCCURRENCES. IF THE DEVICE LEAKED FROM ONE OF THE ADAPTER JUNCTIONS, DID THE DEVICE LEAK FROM THE SEPTUM OR THE THREADING. UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969300 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DID HAVE ANOTHER EVENT YESTERDAY, 11/25/2025, WHERE THE MP5303-C J-LOOP LEAKED AT THE CONNECTION TO THE IV WHILE PUSHING CONTRAST THROUGH THE IV. NO HARM TO PATIENT. WHEN THIS OCCURS, TEAMMATES HAVE BEEN ABLE TO TAKE OFF THE TEGADERM AND TIGHTEN THE CONNECTION AND PROCEED WITH CONTRAST. STATLOCKS ARE BEING USED IN CONJUNCTION WITH IV CATH AND J LOOP. PRODUCT AND PACKAGING WAS SAVED FROM THE J-LOOP. LOT#: (10)25089028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881624 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT ONCE CONTRAST INJECTION WAS STARTED IV STARTED TO LEAK DUE TO J-LOOP NOT BEING TIGHTENED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878006 ↗
• MalfunctionDec 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET HAD LOOSE COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT J-LOOP CONNECTION LOOSENED DURING ANTIBIOTIC. UNKNOWN AMOUNT LEAKED ON THE BED. NURSING HAS NOTICED THIS HAPPENING MORE FREQUENT, AND ONE CASE OF THE J-LOOP NOT LOCKING AND WAS STRIPPED, SO IT NEEDED TO BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858987 ↗
• MalfunctionDec 16, 2025Disconnection; Fluid/Blood Leak; Leak/Splash; Disconnection; Fluid/Blood Leak; Leak/Splash

  ADDITIONAL INFORMATION: NO HARM. IV LEAK DURING CTA HEAD NECK. J-LOOP BECAME DISCONNECTED FROM IV CAUSING CONTRAST AND BLOOD TO LEAK. EXAM HAD TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819196 ↗
• MalfunctionDec 14, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799178 ↗
• MalfunctionDec 12, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿VE RUN INTO ISSUES IN AT LEAST HALF OF THE CASES. SOME LINES RUN, BUT THEY'RE VERY RESTRICTIVE WHEN TRYING TO PUSH FLUIDS OR MEDICATIONS¿REGARDLESS OF HOW CLOSE THE PORT IS TO THE J-LOOP. IN THIS INSTANCE, I ENSURED THE J-LOOP WAS SECURE ON BOTH ENDS AND CHECKED FOR KINKS OR OCCLUSIONS. AS SOON AS I REMOVED THE J-LOOP AND CONNECTED DIRECTLY TO THE CATHETER HUB, IT FLOWED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796554 ↗
• MalfunctionDec 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT LEAKING AT THE POINT BETWEEN THE NEEDLELESS CONNECTER AND THE IV TUBING. ALLOWED BLOOD BACKFLOW. REMOVED PRODUCT AND REPLACED WITH A SECOND EXTENSION SET. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT MEDICATION WAS BEING ADMINISTERED AND LEAKED. WAS THIS A CHEMOTHERAPY DRUG? SALINE WAS BEING FLUSHED THROUGH. NO MEDICATION. WHAT WAS THE IMPACT TO THE PATIENT? THE IMPACT TO THE PATIENT WAS THAT THE IV HAD TO BE TAKEN BACK DOWN TO THE HUB TO HAVE THE DEVICE REPLACED AND REDRESSED. GETTING AN IV ON A CHILD IS DIFFICULT, AND THIS DEVICE CHANGE ADDED TO THE STRESS OF IV PLACEMENT FOR THE CHILD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770729 ↗
• MalfunctionDec 2, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696411 ↗