MaxPlus MP5313-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, (minibore) with removable clear needleless Connector 22 cm (8.5 in) · Class 2
Quick summary
This BD MaxPlus pressure-rated extension set is a short IV tubing set with a removable needleless connector, used to extend intravascular access. The 29 adverse event reports mostly describe fluid or blood leaking from the tubing, hub, or connector, along with sets that became fully blocked and would not flush, and a few loose connections. No deaths or injuries are reported. There are no recalls naming 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403236716), received between Dec 7, 2018 and Dec 1, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (13 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
- Leak/Splash13
- Fluid/Blood Leak5
- Loose or Intermittent Connection3
- Complete Blockage2
- Backflow1
- Connection Problem1
- Free or Unrestricted Flow1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Material Separation; Material Separation
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 A CUSTOMER THAT THE EXTENSION SETS LEAKING AT THE POINT OF ATTACHMENT TO THE IV. ONE CASE WHERE THE EXTENSION SET FELL APART LEADING TO BLOOD LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689140 ↗MalfunctionNov 10, 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 THE CUSTOMER THAT LEAKAGE AT THE HUB AND THE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513255 ↗MalfunctionNov 10, 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: IT WAS REPORTED BY THE CUSTOMER THAT LEAKAGE AT THE HUB AND THE CONNECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513238 ↗MalfunctionNov 10, 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 THE CUSTOMER THAT LEAKAGE AT THE HUB AND THE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513227 ↗MalfunctionNov 10, 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: IT WAS REPORTED BY THE CUSTOMER THAT LEAKAGE AT THE HUB AND THE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513022 ↗MalfunctionNov 7, 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 THE CUSTOMER THAT LEAKAGE AT THE HUB AND THE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498215 ↗MalfunctionAug 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE THREADED CONNECTION IS LOOSE WHICH HAS CAUSED LEAKING TO OCCUR. DESCRIBED THAT STAFF IS NOW TIGHTENING THE BLUE CONNECTOR ON THE LINE BEFORE USING IT ON A PT. THIS SEEMED TO RESOLVE THE ISSUE. PT/CLINICIAN HARM: NO, JUST EXPOSURE TO BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925948 ↗MalfunctionAug 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE THREADED CONNECTION IS LOOSE WHICH HAS CAUSED LEAKING TO OCCUR. DESCRIBED THAT STAFF IS NOW TIGHTENING THE BLUE CONNECTOR ON THE LINE BEFORE USING IT ON A PT. THIS SEEMED TO RESOLVE THE ISSUE. PT/CLINICIAN HARM: NO, JUST EXPOSURE TO BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925937 ↗MalfunctionAug 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE THREADED CONNECTION IS LOOSE WHICH HAS CAUSED LEAKING TO OCCUR. DESCRIBED THAT STAFF IS NOW TIGHTENING THE BLUE CONNECTOR ON THE LINE BEFORE USING IT ON A PT. THIS SEEMED TO RESOLVE THE ISSUE. PT/CLINICIAN HARM: NO, JUST EXPOSURE TO BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925933 ↗MalfunctionAug 7, 2025Leak/Splash; Leak/Splash
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 IS POPPING OFF OF THE EXTENSION SET CAUSING LEAKING AND BLOOD EXPOSURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743022 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD 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 LEAKAGE OCCURRED REPORTED BETWEEN THE INSYTE AG CATHETER HUB AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709243 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708611 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708609 ↗MalfunctionJul 8, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS DIFFICULT TO DISCONNECT, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING ISSUES WITH REMOVING THE WHITE TIP COVER DURING IV INSERTION. HARD TO GET THE MALE PIECE OFF THE SPIN COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436904 ↗MalfunctionNov 14, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WAS BLOCKED DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿EACH SET IS BEING INSPECTED AND FLUSHED FOR PATENCY PRIOR TO USE ON PATIENT. RN HOOKED SALINE FLUSH UP TO EXTENSION SET TO PRIME FOR PATIENT USE. RN WAS UNABLE TO PRIME FLUID THROUGH EXTENSION SET AND REPLACED WITH A DIFFERENT EXTENSION SET THAT PRIMED WITHOUT DIFFICULTY. ON FURTHER INSPECTION, THE DEFECTIVE EXTENSION SET WAS HOOKED TO AN EMPTY SYRINGE AND WITH MODERATE PRESSURE APPLIED EJECTED A PIECE OF WHAT APPEARED TO BE CLEAR PLASTIC. LATER IN THE DAY ANOTHER RN EXPERIENCED THE SAME ISSUE WITH THE SAME PRODUCT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15791394 ↗MalfunctionNov 9, 2021Backflow; Complete Blockage; Free or Unrestricted Flow; Backflow; Complete Blockage; Free or Unrestricted Flow
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR CHECK VALVE MALFUNCTION FAILED, CAUSING FLOW ISSUES AND BLOOD BACKFLOW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS ISSUE IS WITH THE PIGTAIL IV SET. THE RUBBER INSIDE THE VALVE IS NOT CLOSING IN THE OPENING AFTER USE. THE VACUTAINER IS INSERTED, I WITHDRAW BLOOD BUT WHEN I AM DONE AND TRY TO DISCONNECT THE RUBBER INSIDE IS NOT RECOILING AND CLOSING THE VALVE, LEAVING BLOOD TO BACKFLOW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12778018 ↗MalfunctionAug 26, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 8.5 IN PRESSURE RATED MINIBORE SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YES IT WAS THE SAME LOT NUMBER FOR THE CATHETER. WE HAD AN INCIDENT LAST WEEK WHICH WAS ALSO CORRECTED BY PUTTING ANOTHER EXTENSION SET ON. WE THOUGHT IT WAS A ONETIME OCCURRENCE. YESTERDAY I WAS INSERTING AN IV THAT LEAKED AS WELL WHEN FLUSHED. IT LOOKED TO ME THAT IT WAS LEAKING AT THE EXTENSION CONNECTION, SO I REPLACED IT WITH A DIFFERENT TYPE OF EXTENSION SET, MAX BORE, AS OPPOSED TO THE MINI BORE. THIS CORRECTED THE LEAKING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12375565 ↗MalfunctionJul 19, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 8.5 IN PRESSURE RATED MINIBORE SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE EXTENSION SET IS LEAKING AT THE CONNECTION TO CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12194161 ↗MalfunctionJul 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT 4 8.5 IN PRESSURE RATED MINIBORE SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL NURSES REPORTED LEAKAGE FROM THE 22GA IV CATH TO THE EXTENSION SET. I HAD THE IV NURSE PUT ONE TOGETHER IN FRONT OF ME AND NO LEAKAGE WAS DETECTED. I ALSO HAVE THE PACKAGING FROM THE PRODUCT THAT DID AND THE LOT NUMBERS ARE THE SAME. I ASKED IF THEY MADE SURE THE CONNECTION WAS SCREWED TIGHTLY AND SHE CONFIRMED IT WAS AND ALSO INFORMED ME THIS HAPPENED TO FOUR OTHER NURSES. SHE TOLD ME THEY WENT THROUGH SEVERAL EXTENSION SETS BEFORE THEY FOUND ONE THAT DIDN¿T LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12169458 ↗MalfunctionMar 11, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 8.5 IN PRESSURE RATED MINIBORE SET EXPERIENCED COMPONENT SEPARATION AND LEAKS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SET WAS LEAKING BLOOD WHEN THE EXTENSION SET WAS DISCONNECTED FROM THE CONNECTOR. VERBATIM: (B)(6) ED HAS REPORTED TO MM THAT THEY HAVE EXPERIENCED AN ISSUE WITH THE BELOW NOTE ITEM. THE ISSUE WAS WITH ONE OF THE SETS LEAKING BLOOD. (B)(4) SET 0.59 8.5IN EXTENSION MAXPLUS AND REMOVABLE MAXIPLUS CS/50EA WHEN THE EXTENSION SET IS DISCONNECTED FROM THE CONNECTOR IT WILL LEAK BECAUSE THE GASKET IS NOT STICKING. ON 23-FEB-2021 UPDATE: PHOTO OF PACKAGING- THIS JLUPE IS MALFUNCTIONING- THE PLUNGER ON THE CAP IS STICKING + LEAKING X3 ON 2/9 C-POB".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11468103 ↗MalfunctionMar 18, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKED IN THE WOMEN'S & CHILDREN'S PEDIATRIC AND NURSERY DEPARTMENT DURING PATIENT USE WHICH CAUSED THE PATIENT TO HAVE THE IV RESTARTED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429254 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE EXTENSION SET LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143587 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE EXTENSION SET LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143533 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE EXTENSION SET LEAKED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143524 ↗MalfunctionDec 7, 2018Leak/Splash; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED THAT THE EXTENSION SET LEAKED DURING PATIENT USE. THE CUSTOMER STATED THEY BELIEVE THIS TO BE 'USER ERROR,' AS THERE WERE FOUR RELATED EVENTS WITH THE SAME NURSE INVOLVED IN ALL FOUR. THERE WAS NO REPORT OF PATIENT HARM
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8141750 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.