BD PosiFlushRecalls & reported problems across all models

We found 19 models of BD PosiFlush by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,187 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 28, 2026 — classified as 7 deaths, 70 injuries, 1,110 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (389 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD PosiFlush recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 16, 2023Open, Classified

   An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.

   Z-0736-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 14, 2019Terminated

   Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

   Z-0499-2020 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported BD PosiFlush problems

BD PosiFlush models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD PosiFlush 306546

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 death608 reports
• BD PosiFlush 306547

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 death331 reports
• BD PosiFlush 306553

  Saline, vascular access flush
  89 reports
• BD PosiFlush™ 306499

  Saline, vascular access flush
  45 reports
• BD PosiFlush 306424

  Heparin, vascular access flush
  23 reports
• BD PosiFlush 306544

  Catheter,intravascular,therapeutic,short-term less than 30 days
  19 reports
• BD PosiFlush 306513

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 deaths15 reports
• BD PosiFlush 306414

  Heparin, vascular access flush
  11 reports
• BD PosiFlush 306545

  Catheter,intravascular,therapeutic,short-term less than 30 days
  10 reports
• BD PosiFlush 306521

  Catheter,intravascular,therapeutic,short-term less than 30 days
  8 reports
• BD PosiFlush 306413

  Heparin, vascular access flush
  7 reports
• BD PosiFlush 306510

  Catheter,intravascular,therapeutic,short-term less than 30 days
  6 reports
• BD PosiFlush 306423

  Heparin, vascular access flush
  4 reports
• BD PosiFlush 306514

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• BD PosiFlush 306511

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• BD PosiFlush 306512

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 death1 report
• BD PosiFlush 306515

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• BD PosiFlush 306525

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• BD PosiFlush 306531

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report

Recent BD PosiFlush adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Infusion or Flow Problem

  It was reported, Syringe 10 ML saline, pump alarm, line was occluded.The following was provided by the initial reporter: Pt received her aloxi dose on the infusion pump without alarms. A normal saline flush was placed on the microbore tubing and flush was programed on the syringe pump. Syring pump then alarmed that the line was occluded. RN unable to restart the syringe pump without having the occluded alarm. RN was able to hand push the saline flush on the microbore tubing without resistance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913812 ↗
• MalfunctionSep 22, 2026Component Missing

  It was reported, Syringe 10 ml SP Saline, missing white cap, compromising sterility.The following was provided by the initial reporter: Placing PIV for patient, and NaCl syringe in IV start kit was found to have no white cap on it.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854710 ↗
• MalfunctionSep 17, 2026Break

  It was reported, syringe 10 ml saline, tip breakage during use.The following was provided by the initial reporter: Tip of the NS flush broke off into the stopcock of R internal jugular line.additional information:There were not any serious injuries reported to the caregiver or the patient for this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808570 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790363 ↗
• MalfunctionSep 15, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776480 ↗
• MalfunctionSep 13, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747931 ↗
• MalfunctionSep 13, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747930 ↗
• MalfunctionSep 13, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747880 ↗
• MalfunctionAug 26, 2026Tear, Rip or Hole in Device Packaging; Packaging Problem

  No additional information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458134 ↗
• MalfunctionAug 26, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454714 ↗
• MalfunctionAug 18, 2026Contamination; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311077 ↗
• MalfunctionAug 18, 2026Contamination; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311075 ↗
• MalfunctionAug 18, 2026Contamination; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50309164 ↗
• MalfunctionAug 3, 2026Entrapment of Device; Difficult to Remove; Physical Resistance/Sticking

  After placing PIV "[peripheral IV]" and flushing lumen to check patency, saline flush was removed from the connection point to connect the patient to the fluid line. Upon removing flush, there was a very slight amount of resistance. When the flush came off, the inside part of the flush connection was stuck inside of the connection site on the IV. This piece was lodged into the IV and unable to be removed. PIV had to be removed from patient, and a new PIV was placed for treatment.

  Patient problems: Insufficient Information

  MAUDE report 50115656 ↗
• MalfunctionJul 29, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068978 ↗

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