MaxPlus MPX9108-CRecalls & reported problems
BD Switzerland Sàrl · Extension set, with clear needleless connector Y-Site and check valve 32 cm (13 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 10885403274633), received between Mar 10, 2023 and Jan 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2026Crack
IT WAS REPORTED THAT THE BD MAXPLUS EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY IN OUR BONE MARROW UNIT A NURSE HAD SET UP A PCA LINE WITH THE REF#: MPX9108-C AND HAD THE FOLLOWING ISSUE. ¿RN NOTED THAT PATIENTS IV LINE WAS LEAKING BLOOD AND FLUIDS FROM THE IV. SHE NOTED THAT THERE WAS A CRACK IN THE WHITE MALE CONNECTION OF THE PCA EXTENSION TUBING. LINES WERE REMADE AND PATIENT WAS ETHANOL LOCKED FOR INFECTION PREVENTION.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23950696 ↗MalfunctionMar 10, 2023Material Separation; Material Separation
IT WAS REPORTED WHILE USING BD MAXPLUS EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE THE TUBING SEPARATED FROM THE ADAPTOR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MAXPLUS TUBING (ITEM# (B)(4) WAS NOT BONDED TOGETHER LIKE IT SHOULD BE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519725 ↗
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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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