BD PosiFlush 306512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903065127), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 death.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJul 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT WITH A TUNNELED LINE WHO HAD BEEN DIAGNOSED WITH HEART FAILURE, TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018 AND PASSED AWAY. THE PATIENT'S DISCHARGE SUMMARY STATES THAT PATIENT'S MAJOR MEDICAL ILLNESS WAS NON ISCHEMIC CARDIOMYOPATHY, MIXED SEPTIC & CARDIOGENIC SHOCK, HYPOXEMIC RESPIRATORY FAILURE, AND V-TACH ARREST. A 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 3 ML SYRINGE, 10 USP UNITS/ML WAS ASSOCIATED WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)' INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USIN

  Patient problems: Bacterial Infection; Death

  MAUDE report 7696883 ↗