BD PosiFlush 306515Recalls & reported problems
Becton, Dickinson And Company · HEPARIN 100UL 5ML FILL IN 5ML SYRINGE · Class 2
All models of BD PosiFlush (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903065158), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Microbial Contamination of Device1
Patient problems
- Itching Sensation1
- Skin Discoloration1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2018Microbial Contamination of Device
IT WAS REPORTED THAT A PATIENT HAD A ROUTINE BANDAGE CHANGE ON HIS PICC LINE. THE LINE WAS FLUSHED WITH A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML SYRINGE, 100 USP UNITS/ML AT THE PATIENT'S HOME. THE PATIENT EXPERIENCED INTENSE ITCHING AND WENT TO AN INFUSION CENTER WHERE THE PICC LINE WAS REMOVED. THE PATIENT WAS EVALUATED BY HIS PRIMARY CARE PHYSICIAN WHO PRESCRIBED AN ORAL ANTIBIOTIC AND TOPICAL CREAM. THE PATIENT ALSO EXPERIENCED BICEPS DISCOLORATION, SCALY DRY SKIN, AND AN INFECTION. AS OF THE BD AWARENESS DATE, THE PATIENT'S SYMPTOMS REMAIN UNRESOLVED AND A FOLLOW UP APPOINTMENT HAD BEEN SCHEDULED WITH HIS PCP. 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 CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTI
Patient problems: Itching Sensation; Skin Discoloration; Unspecified Infection
MAUDE report 7571441 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page