BD PosiFlush 306414Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903064144), received between Apr 1, 2019 and Nov 20, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML HEPARIN 10 UNIT WAS EMPTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEPARIN SYRINGE EMPTY BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610684 ↗
• MalfunctionMay 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL #306414, BATCH # 434180N. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE LACKED HEPARIN/FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SHARING TWO ADDITIONAL EVENTS OF AIR IN SYRINGE AND LACK OF HEPARIN/FLUID. THESE WERE NOT SAVED FOR RETURN. ASKING FOR ADDITIONAL INVESTIGATION INTO THE MANUFACTURING DEFECT. THE CLOSURE LETTERS I RECEIVED FOR THE PRIOR EVENTS STATE NO ISSUES WITH THE PRODUCTION PROCESS BUT THIS IS AN INCREASING SAFETY TREND FOR THIS PRODUCT. EVENT DATE: 4/18/2025. REF 306414. LOT 434180N. EXP 2026-06-30. EVENT DATE: 4/19/2025. REF 306414. LOT 43410N. EXP 2026-06-30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994747 ↗
• MalfunctionMay 6, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL # 306414 BATCH # 429953N. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE IS EMPTY OF ANY FLUID, BUT THE SYRINGE IS PULLED BACK, CAPPED AND PACKAGED AS THOUGH THERE IS FLUID IN THE SYRINGE. VERBATIM: REPORTING AN ADDITIONAL EVENT THAT OCCURRED TODAY. NOTED BY USER AT TIME OF PREPARATION FOR ADMINISTRATION TO THE PATIENT. LOT #4 29953N EXP: 2026-04-30 PLEASE PROVIDE ME WITH A CONTACT FOR A MANAGER OR DIRECTOR FOR BD¿S QUALITY ASSURANCE TEAM. THIS IS OUR 6TH REPORT OF FINDING A SYRINGE THAT IS EMPTY OF ANY FLUID, BUT THE SYRINGE IS PULLED BACK, CAPPED AND PACKAGED AS THOUGH THERE IS FLUID IN THE SYRINGE. THE FLUID IS CLEAR, SO THE RISK IF THIS IS NOT NOTICED IS THAT AIR IS INJECTED INTO THE PATIENT INSTEAD OF FLUID. IF THIS IS A SMALL INFANT OR A CHILD WITH A RIGHT TO LEFT SHUNT, THE CONSEQUENCES COULD BE CATASTROPHIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968510 ↗
• MalfunctionMay 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL #306414, LOT #429953N. VERBATIM: THIS IS OUR 6TH REPORT OF FINDING A SYRINGE THAT IS EMPTY OF ANY FLUID, BUT THE SYRINGE IS PULLED BACK, CAPPED AND PACKAGED AS THOUGH THERE IS FLUID IN THE SYRINGE. THE FLUID IS CLEAR, SO THE RISK IF THIS IS NOT NOTICED IS THAT AIR IS INJECTED INTO THE PATIENT INSTEAD OF FLUID. IF THIS IS A SMALL INFANT OR A CHILD WITH A RIGHT TO LEFT SHUNT, THE CONSEQUENCES COULD BE CATASTROPHIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962301 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL #306414 BATCH # 434180N IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE LACKED HEPARIN/FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SHARING TWO ADDITIONAL EVENTS OF AIR IN SYRINGE AND LACK OF HEPARIN/FLUID. THESE WERE NOT SAVED FOR RETURN. ASKING FOR ADDITIONAL INVESTIGATION INTO THE MANUFACTURING DEFECT. THE CLOSURE LETTERS I RECEIVED FOR THE PRIOR EVENTS STATE NO ISSUES WITH THE PRODUCTION PROCESS BUT THIS IS AN INCREASING SAFETY TREND FOR THIS PRODUCT. EVENT DATE: (B)(6) 2025. REF (B)(4). LOT 434180N. EXP 2026-06-30. EVENT DATE: (B)(6) 2025. REF (B)(4). LOT 43410N. EXP 2026-06-30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926439 ↗
• MalfunctionApr 3, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL #306414. BATCH #429953N. IT WAS REPORTED BY THE CUSTOMER THAT A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/HEPARIN. THE USER NOTED THE ABSENCE OF FLUID UPON OPENING AND PRIMING FOR INSTALLATION INTO AN ARTERIAL LINE IN THE NICU. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTING AN ADDITIONAL SAFETY EVENT WITH THE BD POSIFLUSH PREFILLED HEPARIN LOCK FLUSH SYRINGE, 5 ML SYRINGE 5 ML HEPARIN FILL, 10 USP UNITS/ML, SKU 306414. A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/HEPARIN. THE USER NOTED THE ABSENCE OF FLUID UPON OPENING AND PRIMING FOR INSTALLATION INTO AN ARTERIAL LINE IN THE NICU. ITEM SAVED AND AVAILABLE FOR RETURN. LOT NUMBER 429953N, EXPIRATION DATE OF 04/30/2026. IT IS THE SAME LOT NUMBER AS THE PREVIOUS REPORT FROM 1/13/25, BD REFERENCE NUMBER (B)(4). ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, CAUGHT BY USER JUST PRIOR TO ADMINISTRATION TO PATIENT. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025. 3. TOTAL NUMBER OF OCCURRENCES? ONE EVENT ON THAT DATE, THREE EVENTS TOTAL. 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761572 ↗
• MalfunctionDec 2, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827874 ↗
• MalfunctionSep 29, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING BD POSIFLUSH¿ PREFILLED HEPARIN LOCK FLUSH SYRINGE THE LABEL WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR INTERN PHARMACISTS WAS DELIVERING THE PRODUCT INTO OUR PYXIS MACHINE ON THE INPATIENT FLOORS. PRODUCT IS NOT LABELED CORRECTLY/NO LABEL IS PLACED ON THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848256 ↗
• MalfunctionMay 10, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ PRE-FILLED HEPARIN LOCK FLUSH SYRINGE WAS MISSING THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEPARIN SYRINGE ONE DID NOT HAVE ANY LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908380 ↗
• InjuryOct 15, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 5ML HEPARIN 10 UNIT LEAKED FLUID WHICH SPLASHED INTO THE NURSES EYE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306414 BATCH NO: UNKNOWN IT WAS REPORTED THAT WHILE INJECTING HEPARIN FROM PREFILLED SYRINGE INTO THE PATIENT'S LINE DURING A BLOOD DRAWING PROCEDURE FLUID FROM THE SYRINGE SPLASHED BACK INTO THE NURSES EYE. VERBATIM: WHILE INJECTING HEPARIN FROM PREFILLED SYRINGE INTO THE PATIENT'S LINE DURING A BLOOD DRAWING PROCEDURE FLUID FROM THE SYRINGE SPLASHED BACK INTO THE NURSES EYE. PATIENT IS ON ONCOLOGY UNIT, BUT NOT OTHER DRUGS OF THERAPIES COULD HAVE CONTRIBUTED AT THE TIME OF THE EVENT. INJECTION OF HEPARIN INTO LINE DURING BLOOD DRAW TO PREVENT CLOTTING.

  Patient problems: Chemical Exposure

  MAUDE report 9191928 ↗
• MalfunctionApr 1, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT A UNSPECIFIED BD SYRINGE HAD LABELING ERROR. THE FOLLOWING WAS REPORTED, "MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED THE HEPARIN LOCKS NO LONGER HAVE BARCODES ON THEM. "GOOD AFTERNOON, WE HAVE BEEN NOTICING OUR HEPARIN AND NS FLUSHES NO LONGER HAVE BARCODES ON THEM? ARE WE ORDERING THE WRONG PRODUCTS OR IS THIS A PERMANENT CHANGE? THANKS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471652 ↗