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BD Vacutainer® 365045Recalls & reported problems

Becton, Dickinson U.K. Limited · BD Vacutainer® Barricor™ Lithium HeparinN Plasma Tubes · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50382903650458), received between Dec 5, 2017 and Jun 13, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Short Fill” (3 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K160657); they may or may not involve this specific model.

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.

Recalls naming this device

  1. Sep 18, 2017Terminated

    Increased amount of residual blood present on the top of stopper well after venipuncture

    Z-1180-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Short Fill3
  • Incorrect Or Inadequate Test Results2
  • Device Operates Differently Than Expected1

Patient problems

  • No Known Impact Or Consequence To Patient5
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 13, 2018Short Fill; Short Fill

    IT WAS REPORTED THAT THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WERE UNDERFILLING. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7599430 ↗
  • MalfunctionMay 11, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

    IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES HAD POOR SEPARATOR MOVEMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7509218 ↗
  • MalfunctionMay 9, 2018Short Fill; Short Fill

    IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES WEREN¿T FILLING COMPLETELY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7500856 ↗
  • MalfunctionMay 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

    IT WAS REPORTED THAT THE BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES TRAPPED THE PLASMA BELOW THE BARRIER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7491410 ↗
  • MalfunctionMay 2, 2018Short Fill; Short Fill

    IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES UNDER FILLED DURING BLOOD COLLECTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7481927 ↗
  • MalfunctionDec 5, 2017Device Operates Differently Than Expected

    IT WAS REPORTED THAT BD VACUTAINER® BARRICOR¿ HAD BLOOD POOLING ON TOP OF STOPPER ONCE REMOVED FROM COLLECTION DEVICE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7083766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160657. One submission often covers many models, so check the product and lot details in each record.

  • Z-1142-2018 · Mar 22, 2018 · Terminated
    BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50

Other Tubes, vials, systems, serum separators, blood collection devices

All Tubes, vials, systems, serum separators, blood collection devices →

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