BD MaxPlus MP9001-CRecalls & reported problems
BD Switzerland Sàrl · Extension set, (minibore) with clear needleless connector 18 cm (7 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403236747), received between Jul 14, 2020 and Mar 8, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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
Device problems
- Leak/Splash1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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