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BD PosiFlush 306423Recalls & reported problems

Becton, Dickinson And Company · SYRINGE 3ML HEPARIN 100 UNIT · Class 2

All models of BD PosiFlush (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903064236), received between Dec 20, 2018 and Nov 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material2
  • Device Markings/Labelling Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT BD POSIFLUSH SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE SYRINGE WAS FOUND ON SATURDAY 10/2/21 WITH BROWN PARTICULATE ON THE INSIDE OF THE SYRINGE BARREL."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12736712 ↗
  • MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE SYRINGE 3ML HEPARIN 100 UNIT SOLUTION WAS A "DEEP YELLOW" INSTEAD OF CLEAR, AND BLACK FOREIGN PARTICLES WERE SEEN FLOATING IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED AND STATED THAT THE SYRINGE IS A DEEP YELLOW COLOR, WHEN IT'S USUALLY CLEAR, AND THERE ARE BLACK PARTICLES FLOATING INSIDE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11853530 ↗
  • MalfunctionOct 1, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT SYRINGE 3ML HEPARIN 100 UNIT CAME WITH A MIX OF PRODUCT TYPES. THIS OCCURRED ON 30 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 30 PCS OF POSIFLUSH 3 ML HEPARIN SALINE RECEIVED INSIDE BOX OF 5 ML HEPARINE SALINE. THAT IS ALSO NEAR EXPIRY WITH EXPIRY DATE OF 30-NOV-2020.

    Patient problems: No Patient Involvement

    MAUDE report 10614409 ↗
  • MalfunctionDec 20, 2018Device Markings/Labelling Problem

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE THERE WAS AN ISSUE WITH NO LABELING ON THE PRODUCT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8186835 ↗

Other Heparin, vascular access flush devices

All Heparin, vascular access flush devices →

Sources and updates

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