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IV Plus® BD6010Recalls & reported problems

Nexus Medical, LLC · Blood Collection Assembly with Male Luer Lock · Class 1

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10815879021011), received between Dec 4, 2018 and Dec 4, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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

Device problems

  • Crack5
  • Leak/Splash4
  • Appropriate Device Problem Term/Code Not Available3

Patient problems

  • Blood Loss3
  • No Information3

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 4, 2018Leak/Splash

    DRAWING LABS FROM PATIENT AND BLOOD LEAKED OUT OF THE VACUTAINER LUER LOC.

    Patient problems: Blood Loss

    MAUDE report 8128158 ↗
  • MalfunctionDec 4, 2018Crack; Leak/Splash; Appropriate Device Problem Term/Code Not Available

    NURSE DRAWING LABS, COULDN'T DRAW LABS AS DEVICE CRACKED AND BLOOD LEAKING.

    Patient problems: Blood Loss

    MAUDE report 8128157 ↗
  • MalfunctionDec 4, 2018Crack; Leak/Splash

    NURSE ATTEMPTING TO DRAW BLOOD AND DISCONNECT LUER LOCK AT PATIENT. BLOOD LEAKED AND THE LUERLOCK CRACKED AND STUCK IN THE NEEDLELESS CONNECTOR. BLOOD EXPOSURE.

    Patient problems: Blood Loss

    MAUDE report 8128156 ↗
  • MalfunctionDec 4, 2018Crack; Appropriate Device Problem Term/Code Not Available

    NURSE DRAWING LABS, COULDN'T DRAW LABS AS DEVICE CRACKED AND BLOOD LEAKING.

    Patient problems: No Information

    MAUDE report 8128155 ↗
  • MalfunctionDec 4, 2018Crack; Leak/Splash

    NURSE DRAWING LABS AND BLOOD BEGAN LEAKING AT THE NEEDLELESS CONNECTOR, VACUTAINER HAD CRACKED AT THE LUER LOCK TIP.

    Patient problems: No Information

    MAUDE report 8128130 ↗
  • MalfunctionDec 4, 2018Crack; Appropriate Device Problem Term/Code Not Available

    PATIENT HAVING A LAB DRAW BY NURSE AND THE VACUTAINER CRACKED IN THE CLAVE AND BLOOD COULD NOT BE WITHDRAWN.

    Patient problems: No Information

    MAUDE report 8128129 ↗

Other System, Blood Collection, Vacuum-Assisted, Manual devices

All System, Blood Collection, Vacuum-Assisted, Manual devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.