BD PosiFlush 306413Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 3ML HEPARIN 10 UNIT · Class 2
All models of BD PosiFlush (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903064137), received between Feb 13, 2018 and Oct 21, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem3
- Failure to Deliver1
- Fluid/Blood Leak1
- Packaging Problem1
- Volume Accuracy Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:306413, BATCH#:417935N, 411439N. IT WAS REPORTED BY CUSTOMER THAT THE DEFECT FOUND IN 2 HEPARIN 30UNITS/3ML SYRINGES DISCOVERED THIS MORNING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANT TO REPORT A DEFECT FOUND IN 2 HEPARIN 30UNITS/3ML SYRINGES DISCOVERED THIS MORNING (10/17). PRODUCT NAME AND/OR CATALOG NUMBER: HEPARIN FLUSH 30 UNIT/3ML SYRINGE LOT NUMBER OR SERIAL NUMBER: SYRINGE ON LEFT: NDC (B)(4) EXP 2025-12-31 LOT 417935N SYRINGE ON RIGHT: (B)(4) EXP 2025-10-31 LOT 411439N ANY INJURIES AND/OR HARM? NO. WHAT IS THE ISSUE YOU EXPERIENCED? SYRINGE ON THE LEFT HAS THE LABEL IN THE INCORRECT POSITION. SYRINGE ON THE RIGHT HAS THE INCORRECT VOLUME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495723 ↗MalfunctionMar 24, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT SCALE MARKINGS WERE MISSING ON THE BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE THEY TOOK THE SYRINGE OUT FROM THE WRAPPER, THE INNER SYRINGE WAS UNLABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13893198 ↗MalfunctionOct 21, 2021Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD POSIFLUSH¿ HEPARIN SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS THE NURSE ATTEMPTED TO PRIME THE SYRINGE THE PLUNGER BECAME DISLODGED FROM THE SEAL. IT EXPECTED THAT THE HEPARIN SYRINGE PLUNGERS ARE STICKY AND HAVE TO LOOSEN IT BY PULLING IT OUT THEN IN. IN THIS CASE THIS PLUNGER BECAME DISLODGED WHILE THE NURSE WAS DOING THIS. THE NURSE GOT A NEW HEPARIN SYRINGE AND THIS ISSUE DID NOT REACH THE PT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12674562 ↗MalfunctionJan 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT SYRINGE 3ML HEPARIN 10 UNIT WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306413, BATCH NO.: 022362N. IT WAS REPORTED THAT THE BARCODE ON THE SYRINGES ARE CUT OFF AND CANNOT BE SCANNED.
Patient problems: No Patient Involvement
MAUDE report 11152747 ↗MalfunctionOct 15, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
MATERIAL NO: 306413; BATCH NO: UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 3ML HEPARIN 10 UNIT THE SYRINGE HAS INCORRECT DATA RELATED TO LATEX IN THE FDA GUDID DATABASE. THE LABEL FOR THIS PRODUCT STATES "THIS PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX OR PRESERVATIVES". THE DATA IN THE GUDID SUGGESTS OTHERWISE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "THE POSIFLUSH SYRINGE HAS INCORRECT DATA RELATED TO LATEX. THE LABEL FOR THIS PRODUCT STATES "THIS PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX OR PRESERVATIVES". THE DATA IN THE GUDID SUGGESTS OTHERWISE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9194434 ↗MalfunctionMay 18, 2018Packaging Problem
IT WAS REPORTED THAT A PACKAGE OF BD¿ HEPARIN SYRINGE(S) WERE RECEIVED WITHOUT LABELS, BARCODES OR EXPIRATIONS LABELS. THE SYRINGES WERE NOT USED AND THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7526556 ↗MalfunctionFeb 13, 2018Fluid/Blood Leak
IT WAS REPORTED THAT MULTIPLE TIMES, THE PLUNGER OF A BD¿ SYRINGE 3ML HEPARIN 10 UNIT WILL ¿COME OUT¿ WHILE DRAWING UP MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7268220 ↗
Other Heparin, vascular access flush devices
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- PENDING EMZH60051Medline Industries, Inc. · Heparin, vascular access flush1 recall0 reports
- BD PosiFlush 306424Becton, Dickinson And Company · Heparin, vascular access flush23 reports
- BD PosiFlush 306414Becton, Dickinson And Company · Heparin, vascular access flush11 reports
- BD PosiFlush 306423Becton, Dickinson And Company · Heparin, vascular access flush4 reports
- Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
- Heparin Lock Flush Syringe 100 Unit/mL 3mL in 6mL syringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
- Heparin Lock Flush Syringe 1 unit/mL 2 mL in 6mL SyringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
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.
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