BD PosiFlush 306547Recalls & reported problems

Summary

The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 00382903065479), received between Nov 27, 2017 and Sep 22, 2026 — classified as 1 death, 13 injuries, 317 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (156 reports).

2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 29, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068978 ↗
• MalfunctionMay 25, 2026Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272399 ↗
• MalfunctionMay 21, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. ADDITIONAL INFORMATION: -SYRINGE MEDICATION / ALARIS PUMP SHOWING "OCCLUDED" DESPITE TROUBLESHOOTING. MEDICATION WAS MADE BY NURSE ON THE FLOOR- IV GRAVOL AND 10ML PRE-FILLED SYRINGE. PT'S NAUSEA WOULD NOT BE ADDRESSED AND PT WOULD CONTINUE TO FILL DISCOMFORT. NO HARM TO THE PATIENT.

  Patient problems: Inadequate Pain Relief; Nausea

  MAUDE report 25243293 ↗
• MalfunctionMay 21, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. ADDITIONAL INFORMATION THE PATIENT WAS RECEIVING A MEDICATION (MADE BY NURSING) VIA IV SYRINGE. WE MADE THE MEDICATION USING THE SALINE FLUSH SYRINGES. THERE WAS 10ML OF VOLUME, ONLY 4ML WENT IN AND THE PUMP BEGAN TO ALARM CONSISTENTLY. WE TRIED RESECURING DIFFERENT CONNECTIONS, BUT THIS DID NOT WORK. WE HAD TO CHANGE THE SYRINGE TO A REGULAR, EMPTY 10ML SYRINGE, AND ONLY AT THIS CHANGE DID THE PUMP WORK AGAIN. IF SYRINGES CONTINUE TO BE MALFUNCTIONING, MEDICATIONS WILL NOT BE ADMINISTERED IN A TIMELY MANNER AND OTHER MEDS/PATIENT CARE BECOME DELAYED. ON TOP OF THIS, PATIENTS WILL NOT RECEIVE THEIR MEDICATIONS EFFICIENTLY, THEREFORE PROLONGING ANY SYMPTOMS/ILLNESS. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243291 ↗
• MalfunctionMay 18, 2026Pumping Problem

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 306547 BATCH#: UNKNOWN VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED BD #306547: BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE, 10 ML SYRINGE 10 ML SALINE FILL OUR TEAM IS INDICATING THERE IS A LIP ON THE FLANGE OF THE SYRINGE CAUSING THE MEDFUSION PUMPS TO ALERT WITH A MESSAGE OF "OCCLUSION." HAS SOMETHING CHANGED WITH THESE? THE REGULAR SYRINGES DON'T HAVE THIS LIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209589 ↗
• MalfunctionMay 8, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS.NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123130 ↗
• MalfunctionMay 8, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10 ML PUMP COMPATIBLE SALINE 10 ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122925 ↗
• MalfunctionMay 8, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122923 ↗
• MalfunctionMay 8, 2026Infusion or Flow Problem

  IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122915 ↗
• MalfunctionApr 15, 2026Contamination

  IT WAS REPORTED, "BD NS PRE-FILLED FLUSH SYRINGE THAT HAS A SUBSTANCE OF SOME SORT FLOATING AROUND IN IT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885368 ↗
• MalfunctionFeb 27, 2026Disconnection

  IT WAS REPORTED THAT THE BD MAXPLUS NEEDLELESS CONNECTOR HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD A QUALITY ISSUE REPORTED FROM THE ER. NO ONE ELSE HAS REPORTED ANYTHING BUT I STILL WANTED TO SEND IT YOUR WAY JUST IN CASE THERE HAVE BEEN OTHER REPORTS TO BD. I HAVE COPIED THEIR STATEMENT BELOW. "HAS ANYONE COMPLAINED ABOUT THE MAXIPLUS CONNECTOR (MP1000-C) OR THE BD POSIFLUSH SALINE FLUSH (306547)? I HAVE 2 LOT NUMBERS FOR THE MAXIPLUS MP1000-C THAT WILL NOT STAY CONNECTED TO THE SALINE FLUSH AND TWO LOT NUMBERS FOR THE SALINE FLUSH. I CANNOT TELL WHICH ONE IS NOT FUNCTIONING PROPERLY DUE TO LIMITED LOT NUMBERS. WHEN CONNECTED TOGETHER, THE MAXIPLUS WILL ACTUALLY UNSCREW ITSELF FROM THE SALINE SYRINGE. THIS IS THE FIRST NOTIFICATION FROM STAFF THAT I HAVE RECEIVED ON THIS ISSUE." MP1000-C - LOTS 25125311, 25115892.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466353 ↗
• MalfunctionFeb 25, 2026Material Discolored

  IT IS REPORTED CLOUDY SALINE SYRINGE. DESCRIBE THE EVENT OR PROBLEM: THE NURSE GRABBED A SALINE FLUSH OUT OF THE STORAGE CONTAINER AND NOTED THAT THE SYRINGE WAS CLOUDY. THE LOT NUMBER WAS WRITTEN DOWN. LOOKED THROUGH ALL THE OTHER SALINE SYRINGES PRESENT AND NO OTHER CLOUDINESS WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443443 ↗
• MalfunctionFeb 18, 2026Contamination

  THERE IS A FOREIGN BODY INSIDE THE SYRINGE. LOOKS TO BE A BROKEN PIECE FROM ANOTHER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379439 ↗
• MalfunctionJan 23, 2026Contamination

  IT WAS REPORTED BUG PARTS IN THE SYRINGE. VERBATIM: 1ST SYRINGE LOOKED LIKE IT WAS BUG PARTS AND SHE HAD PUSHED MOST INTO HER SYSTEM BEFORE NOTICING.

  Patient problems: Insufficient Information

  MAUDE report 24161536 ↗
• MalfunctionJan 23, 2026Contamination

  IT IS REPORTED FOREIGN MATTER-RUBBER. THE 2ND LOOKED LIKE PIECES OF RUBBER, BUT SHE NOTICED RIGHT AWAY AND DIDN¿T USE. THIS IS THE ONE SHE STILL HAS.

  Patient problems: Insufficient Information

  MAUDE report 24161526 ↗
• MalfunctionJan 22, 2026Infusion or Flow Problem

  IT IS REPORTED PUMP COMPATIBILITY ISSUES. VERBATIM: EVENT DESCRIPTION: WHEN USING THESE SALINE FLUSHES, THE PUMPS WILL CONTINUOUSLY BEEP OCCLUDED. OUTCOME: INFUSION INTERRUPTIONS, NEED TO REPLACE SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145016 ↗
• MalfunctionJan 22, 2026Infusion or Flow Problem

  IT IS REPORTED PUMP COMPATIBILITY ISSUES. EVENT DESCRIPTION: WHEN USING THESE SALINE FLUSHES, THE PUMPS WILL CONTINUOUSLY BEEP OCCLUDED. OUTCOME: INFUSION INTERRUPTIONS, NEED TO REPLACE SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145013 ↗
• MalfunctionJan 20, 2026Contamination

  IT WAS REPORTED BY CUSTOMER THAT LOOK LIKE "MOLD" ON THE SALINE SYRINGES IN MULTIPLE BOXES. INITIAL DESCRIPTION: MATERIAL 306547 LOT 5261637. I AM REACHING OUT REGARDING A PRODUCT REPORT FROM ONE OF OUR SITES. PLEASE FIND BELOW THE INCIDENT DETAILS AND ALL RELEVANT INFORMATION NEEDED FOR YOUR INTERNAL TEAM TO REVIEW AND PROCESS THE REPORT. I¿VE ATTACHED IMAGES AS WELL. GOOD CATCH AS ANESTHESIA NOTICED WHAT APPEARS TO LOOK LIKE "MOLD" ON THE SALINE SYRINGES IN MULTIPLE BOXES THAT WERE TO BE STOCKED. ALL PRODUCT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116561 ↗
• MalfunctionJan 16, 2026Nonstandard Device

  IT IS REPORTED THAT THE SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL BARREL / FLANGE IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: THREE MEDFUSION 4000 SYRINGE PUMPS HAVE COME DOWN TO CLINICAL ENGINEERING IN A SHORT TIME FRAME ALL REPORTING THE SAME PROBLEM: ¿SYRINGE PLUNGER NOT IN PLACE¿ WITH AN ARROW POINTING TO A REPRESENTATION OF THE SYRINGE BARREL FLANGE. M333717, M333711, M909775 A WORK ORDER DATED 09-DEC-2025 WAS FOUND DOCUMENTING THE PROBLEM; THE PUMP SUBSEQUENTLY CAME BACK TO CE WITH THE SAME ISSUE RECENTLY. NO FAULTS WERE FOUND WITH THE PUMPS WHEN BENCH TESTED. THIS APPEARS TO BE AN ISSUE WITH PREFILLED 10ML BD SYRINGES. SOME 10ML BD SYRINGES HAVE BEEN FOUND TO HAVE NARROWER FLANGES. (1.5MM VS 2.0MM). STAFF COULD BE INFORMED THAT REPOSITIONING THE BARREL CAN ALLEVIATE THE PROBLEM, OR THE SYRINGES WITH THE NARROW FLANGES REMOVED FROM CIRCULATION. NO SERIOUS HARM WAS REPORTED. UNFORTUNATELY, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION PROVIDED: IN NONE OF THE CASES THE SYRINGES WERE SUPPLIED TO CLINICAL ENGINEERING FOR ANALYSIS. HOWEVER, FINDING OUR OWN PREFILLED 10ML FOR TESTING RESULTED IN THE SAME ERRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101219 ↗
• MalfunctionJan 14, 2026Nonstandard Device

  IT IS REPORTED SOME 10ML BD SYRINGES HAVE BEEN FOUND TO HAVE NARROWER FLANGES. INCIDENT DETAILS: THREE MEDFUSION 4000 SYRINGE PUMPS HAVE COME DOWN TO CLINICAL ENGINEERING IN A SHORT TIME FRAME ALL REPORTING THE SAME PROBLEM: ¿SYRINGE PLUNGER NOT IN PLACE¿ WITH AN ARROW POINTING TO A REPRESENTATION OF THE SYRINGE BARREL FLANGE. M333717 M333711 M909775 A WORK ORDER DATED 09-DEC-2025 WAS FOUND DOCUMENTING THE PROBLEM; THE PUMP SUBSEQUENTLY CAME BACK TO CE WITH THE SAME ISSUE RECENTLY. NO FAULTS WERE FOUND WITH THE PUMPS WHEN BENCH TESTED. THIS APPEARS TO BE AN ISSUE WITH PREFILLED 10ML BD SYRINGES. SOME 10ML BD SYRINGES HAVE BEEN FOUND TO HAVE NARROWER FLANGES. (1.5MM VS 2.0MM). STAFF COULD BE INFORMED THAT REPOSITIONING THE BARREL CAN ALLEVIATE THE PROBLEM, OR THE SYRINGES WITH THE NARROW FLANGES REMOVED FROM CIRCULATION. ADDITIONAL INFORMATION ON 09-JAN-2026. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR LOT# 5024175? <- 09 DEC 2025 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. <- INABILITY TO START DRUG INFUSION WHEN INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069473 ↗
• MalfunctionJan 12, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL BARREL / FLANGE WAS DAMAGED. MATERIAL#: 306547, BATCH#: 5162313. RCC RECEIVED A COMPLAINT VIA EMAIL. THIS NURSE WAS GIVING A PULSE FLUSH TO A CENTRAL LINE, AND THE FLUSH PLASTIC PIECES BROKE OFF AND CUT THIS NURSES FINGER. CUT ON FINGER IS SMALL AND ONLY REQUIRED FIRST AID OF CLEANSING AND BAND AID. THE CUT LOOKS GOOD TODAY, NO S/S [SIGNS/SYMPTOMS] OF INFECTION AND WOUND IS HEALING. NURSE WAS SQUEEZING A FLUSH SYRINGE AND WHILE PULSATILE FLUSHING THE FLANGE ON THE FLUSH SYRINGE BROKE AND THAT IS WHAT CUT HIS FINGER. PRODUCT#: 306547, LOT#: 5162313.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046684 ↗
• MalfunctionJan 7, 2026Contamination

  IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306547 BATCH#: 5238612 RCC RECEIVED A COMPLAINT VIA EMAIL. XXX MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT: (B)(6) 2025 TYPE OF INCIDENT/PROBLEM: A2. FAILURE. (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: XXXX OPTIONAL REPORT TO (B)(6): INCIDENT DETAILS: PT WAS SHOWING SIGNS OF DISCOMFORT, DESPITE BEING SEDATED ON AN INFUSION OF PROPOFOL. NURSE ASKED FOR AN ORDER OF TORADOL WHICH WAS ORDERED BY THE RESIDENT ASSIGNED TO THE PT. NURSE PREPARED AND ADMINISTERED THE ORDERED DOSE. AS THE NURSE COMPLETED FLUSHING THE MEDICATION THROUGH THE PT'S IV LINE, THEY NOTICED SOMETHING FLOATING IN THE PREPACKAGED SALINE FLUSH SYRINGE. UPON FURTHER INSPECTION THE NURSE NOTED WHAT APPEARS TO BE A PIECE OF BROKEN SYRINGE TUBING INSIDE THE FLUSH SYRINGE THAT HAD JUST BEEN USED TO FLUSH THE PT'S IV. NURSE DID NOT NOTE ANY RESISTANCE WHILE FLUSHING THE IV AND THE PT APPEARED UNBOTHERED AS WELL. THE IV SITE REMAINS INTACT, WITH NO SWELLING, OR LEAKING. NURSE NOTIFIED CHARGE NURSE AND IMMEDIATELY SUBMITTED THE RLS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994309 ↗
• MalfunctionJan 2, 2026Contamination

  IT WAS REPORTED THAT BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL CONTAINED FOREIGN MATTER. VERBATIM: PATIENT STATES THERE IS SOMETHING BLACK FLOATING IN THE SYRINGE THAT LOOKS LIKE A BUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949268 ↗
• MalfunctionDec 11, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306547, LOT#: 5212357. RCC RECEIVED A COMPLAINT VIA EMAIL. PIR TEAM CAN WE START INVESTIGATION ON #306547 10ML FLUSH ¿ CUSTOMER CONTACT INFORMATION AND REPORT BELOW: I NEED TO REPORT A PRODUCT QUALITY ISSUE OF THE BD SYRINGE PFILL 10ML FLUSH 9% NACL STERILE, MFG# 306547; SOME NURSING UNITS THAT ARE FINDING WHAT APPEARS TO BE MOLD IN THEIR 10ML SALINE FLUSHES. LOT: 5212357, EXP: 06-30-2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785833 ↗