MaxZero MZ9324Recalls & reported problems
BD Switzerland Sàrl · Minibore quad-fuse extension set, 2 IV connectors, 2 filters 18 cm (7 in) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403427237), received between Jan 10, 2019 and Jan 10, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE USER NOTED THAT THE BABY'S BLANKET WAS DAMP. THE RN PLACED A GAUZE UNDERNEATH THE UVC (PATIENT UMBILICAL VENOUS CATHETER) TRI-PORT AND FOUND IT TO BE LEAKING. UPON CLOSER OBSERVATION, THE "LIPID LINE" EXTENSION SET WAS NOTED TO BE CRACKED AND LEAKING AT THE BASE OF THE FILTER. THE USER HAD TO DISCONTINUED THE LIPID INFUSION AND CHANGED OUT THE LINES. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8236172 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.