BD PosiFlush 306544Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00382903065448), received between Dec 6, 2018 and Feb 5, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313450 ↗
• MalfunctionMay 26, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT 1 BD SYRINGE 3ML SALINE 3ML FILL HAD MISSING LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED A PLAIN 0.9% SODIUM CHLORIDE 3 ML FLUSH SYRINGE WITH FLUID INSIDE BUT WITHOUT ANY LABELING. IT DOES NOT HAVE ANYTHING ON IT INCLUDING NAME OF THE FLUID AND THE ML MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14514073 ↗
• MalfunctionJul 8, 2021Inappropriate Audible Prompt/Feedback; Improper Flow or Infusion; Inappropriate Audible Prompt/Feedback; Improper Flow or Infusion

  IT WAS REPORTED THAT SYRINGE 3ML SALINE 3ML FILL ALARMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SYRINGE CAUSES OCCLUSION ALARMS AND IS NOT COMPATIBLE WITH THE ALARIS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134554 ↗
• MalfunctionJun 23, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 5 SYRINGE 3ML SALINE 3ML FILL EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306544, BATCH NO: UNKNOWN. WCS MANAGER IS STATING THEY CAN¿T USE THE NEW FLUSHES BECAUSE THEY ARE HARD TO FLUSH AND POTENTIAL TO BLOW IV LINES FOR NICU BABIES. SHE SAYS THEY HAVE TO USE THE LONGER SKINNY FLUSH. CNO AGREED AND THE COMPROMISE WAS WE WOULD ONLY ADD BACK TO THAT ONE FLOOR.¿ ALONG WITH THERE NOT BEING A SMOOTH DELIVERY OF FLUSH THROUGH THE SHORT 3 ML NS SYRINGES, THE SHORT SYRINGE IS DIFFICULT TO MANAGE WHEN YOU HAVE A SMALL APPENDAGE AND 6 HANDS TRYING TO HOLD, TAPE, AND STABILIZE THE IV, T-CONNECTOR, CLEAR CAP, AND SYRINGE. THE SYRINGE IS TOO BULKY FOR EASE OF ACCESS TO IT OR TRYING TO KEEP IT IN POSITION SO THAT IT DOESN¿T PULL ON THE TUBING. WE ALL ENCOUNTERED DIFFICULTIES WITH BOTH ADMITS YESTERDAY. NUMBER OF OCCURRENCES: 5.0

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054625 ↗
• MalfunctionFeb 10, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 9 SYRINGE 3ML SALINE 3ML FILL EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON OPENING A BOX OF 0.9% SODIUM CHLORIDE INJECTION  BD POSIFLUSH NORMAL SALINE FLUSH SYRINGE (REF # 306544), 9 SYRINGES WERE IN THE SEALED PLASTIC OVERWRAP THAT DO NOT HAVE MARKINGS ON THE SYRINGE TO DENOTE CONTENTS, LOT, EXP, OR MEASUREMENTS. BELOW IS THE INFORMATION REGARDING THE BOX THE PRODUCT WAS IN: " 0.9% SODIUM CHLORIDE INJECTION, BD POSIFLUSH SYRINGE REF # 306544 " LOT 0230934M EXP 8/31/2023 " NO INJURIES THAT WE ARE AWARE OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11311742 ↗
• MalfunctionJan 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PINK, FOREIGN SUBSTANCE WAS FOUND ON THE SYRINGE 3ML SALINE 3ML FILL HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PINK SUBSTANCE ON SYRINGE HUB".

  Patient problems: No Patient Involvement

  MAUDE report 11174418 ↗
• MalfunctionJan 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 3ML SALINE 3ML FILL EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306544 BATCH NO: 0203206. PRODUCT NAME AND/OR CATALOG NUMBER: BD POSIFLUSH (3ML NS FLUSH). LOT NUMBER OR SERIAL NUMBER: 0203206. ANY INJURIES AND/OR HARM? NONE KNOWN. WHAT IS THE ISSUE YOU EXPERIENCED? PINK SUBSTANCE ON SYRINGE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11163573 ↗
• MalfunctionNov 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 SYRINGE 3ML SALINE 3ML FILL EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306544 BATCH NO: 0210090, 0043481. I AM INQUIRING ABOUT THE USE OF THE 3ML POSIFLUSH WITH A 24 GAUGE INSTYE AUTOGUARD W/O BLOOD CONTROL IV CATHETER. HOSPITAL RECENTLY SWITCHED FROM A STANDARD 3ML SYRINGE TO THE POSIFLUSH 3ML STUBBY DESIGN AND IS EXPERIENCING MORE BLOWN IV SITES THAN USUAL. THEY'VE PINPOINTED THE USE OF THE STUBBY FLUSH AS THE STEP IN THE PROCESS WHERE THEY ARE BLOWING THE LINE, FEARING IT IS THE GREATER FORCE AND PRESSURE BEHIND THE PLUNGER ROD. I DID EXPLAIN THAT THE BY DESIGN, THE STUBBY FLUSH ACTUALLY HAS SIGNIFICANTLY LESS PSI FORCE AND REFLUX COMPARED TO THE STANDARD DESIGN, AND REVIEWED THEIR FLUSHING TECHNIQUE, RECOMMENDING A PUSH PAUSE METHOD. THE MEDICAL SUPPORT TEAM SUGGESTED I SUBMIT THIS IS AS A COMPLAINT, SHOULD THERE BE SOMETHING DEFECTIVE ABOUT THE IV OR FLUSH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795789 ↗
• MalfunctionOct 9, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT ONE BD SALINE VASCULAR ACCESS FLUSH HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT STAFF IS HAVING ISSUES PRIMING/FLUSHING. PER ATTACHED NOTE ON BAG: TRIFURCATE NOT FLUSHING HAD TO GO THROUGH COUPLE BEFORE ONE WORKED. PLEASE ADVISE WHAT ADDITIONAL INFORMATION IS NEEDED."

  Patient problems: Insufficient Information

  MAUDE report 10657204 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ONE BD SALINE, VASCULAR ACCESS FLUSH SPUN OUT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE BIFURCATES SPUN WHEN TRYING TO CONNECT IVF TO PIV. PER ATTACHED NOTE ON BAG: BOTH OF THESE BIFURCATES JUST "SPINNED" WHEN I TRIED TO CONNECT MY IVF TO MY PIV HAD TO USE A TRIFURCATE."

  Patient problems: Insufficient Information

  MAUDE report 10646254 ↗
• MalfunctionOct 6, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT THE SYRINGE 3ML SALINE 3ML FILL WOULD NOT FLUSH THE PORT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO FLUSH PORT WHEN HANGING IVF."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639410 ↗
• InjuryJan 30, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML SALINE 3ML FILL HAS BEEN FOUND EXPERIENCING DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306544 BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE SYRINGE WILL NOT ALLOW YOU TO INFUSE MORE THAN 3MLS. DIRECT EMAIL FROM CUSTOMER: WE HAVE BEEN ALERTED BY 3 HOSPITALS' NICUS THAT THERE IS ISSUE W/THE BD PRE-FILL 3ML NS FLUSH SYRINGES. FIRST SHOWS THAT THE BD SYRINGE HAS THE SAME BARREL SIZE AS THE 10ML PRE-FILL FLUSH. SECOND SHOWS THE OLE MEDLINE 3ML SYRINGE, & THE BARREL SIZE IS SMALLER. NICUS UTILIZE THE ALARIS SYRINGE MODULE TO FLUSH, WHICH DOES READ IT AS A 10ML BARREL BUT WON'T LET YOU INFUSE MORE THAN 3MLS. IT DOES READ A 10 ML BARREL BUT IT WILL NOT LET YOU INFUSE MORE THAN THE 3 MLS.. IT WON'T EVEN LET YOU PUT IN ANYTHING MORE THAN 3.ML. I HAVE ANOTHER CONCERN THAT MY STAFF THINKS THESE ARE BLOWING THE IV'S THAT THEY START.. THEY THINK THE PRESSURE IS DIFFERENT. WE DEAL WITH VERY SMALL PATIENTS LIKE UNDER 1 POUND AND THEY CLAIM THESE FLUSHES BLOW THE IV'S THEY ARE STARTING. IT ALSO FEELS LIKE THE BARREL IS HARDER TO PUSH. THE MAJOR CONCERN IS THAT THESE 3ML SYRINGES SEEM TO BE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9648743 ↗
• MalfunctionJan 30, 2020Short Fill; Short Fill

  IT WAS REPORTED THAT THE ENTIRE FLUSH IS NOT BEING DELIVERED WITH A BD SYRINGE 3ML SALINE 3ML FILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3 COMPLAINTS) IT WAS REPORTED THE CUSTOMER RECENTLY SWITCHED OVER FROM HAVING 0.45% NORMAL SALINE FLUSHES PREPARED IN THE HOSPITAL PHARMACY TO BD 3ML .9% NORMAL SALINE FLUSHES. SINCE THE SWITCH THEY HAVE BEEN GETTING CONCERNS FROM THE NURSING STAFF ABOUT THE ENTIRE FLUSH AMOUNT NOT BEING DELIVERED THAT WAS PROGRAMMED. AFTER A MEETING ON MONDAY SOME OF THE NURSES DECIDED TO TEST IT OUT AND, FROM WHAT THEY WERE ABLE TO MEASURE, ONLY 0.4ML WAS DELIVERED EACH TIME INSTEAD OF THE 0.6ML THAT WAS PROGRAMMED. ADDITIONALLY, ON 2020-01-27 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHAT ARE THE LOT #¿S USED FOR REF # (B)(4)? WE HAVE NDC, NOT LOT NUMBERS. WHAT WAS THE DATE THIS INCIDENT TOOK PLACE? USE 1/15 FOR THE PURPOSE OF THE REPORT. ARE ANY SAMPLES AVAILABLE FROM EACH MATERIAL NUMBER TO BE RETURNED TO BD FOR EVALUATION? IF SO A (B)(4) SHIPPING LABEL WILL BE PROVIDED. YOU ARE WELCOME TO USE YOUR OWN INVENTORY OF 3 ML FLUSH SYRINGES. IF YOU WOULD LIKE US TO SEND A 3 ML FLUSH SYRINGE TO YOU WE CAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9648608 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE PLUNGER MOVEMENT WAS DIFFICULT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE SYRINGE WILL NOT ALLOW YOU TO INFUSE MORE THAN 3MLS. 3 OF 3: DIRECT EMAIL FROM CUSTOMER: WE HAVE BEEN ALERTED BY 3 HOSPITALS' NICUS THAT THERE IS ISSUE W/THE BD PRE-FILL 3ML NS FLUSH SYRINGES. NICUS UTILIZE THE ALARIS SYRINGE MODULE TO FLUSH, WHICH DOES READ IT AS A 10ML BARREL BUT WON'T LET YOU INFUSE MORE THAN 3MLS. IT DOES READ A 10 ML BARREL BUT IT WILL NOT LET YOU INFUSE MORE THAN THE 3 MLS.. IT WON'T EVEN LET YOU PUT IN ANYTHING MORE THAN 3.ML. I HAVE ANOTHER CONCERN THAT MY STAFF THINKS THESE ARE BLOWING THE IV'S THAT THEY START.. THEY THINK THE PRESSURE IS DIFFERENT. WE DEAL WITH VERY SMALL PATIENTS LIKE UNDER 1 POUND AND THEY CLAIM THESE FLUSHES BLOW THE IV'S THEY ARE STARTING. CAN YOU FIND OUT IF THE PRESSURE IS GREATER. IT ALSO FEELS LIKE THE BARREL IS HARDER TO PUSH. HOWEVER, THE MAJOR CONCERN IS THAT THESE 3ML SYRINGES SEEM TO BE INFUSING W/MORE PRESSURE SO THAT IT BLOWS THESE NICU BABIES IVS. WE NEED THIS INVESTIGATED ASAP. IF THESE D

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9635856 ↗
• MalfunctionJul 17, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD POSIFLUSH¿ NORMAL SALINE SYRINGE PUMP IS NOT GIVING THE CORRECT VOLUME. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306544 BATCH NO: UNKNOWN IT WAS REPORTED THAT THE PUMP IS UNABLE TO DETECT THE SYRINGES AND IS NOT DELIVERING THE CORRECT VOLUME. DESCRIPTION OF PROBLEM: THESE 3ML NS FLUSHES (LARGER BARREL THAN THE PREVIOUS 3ML NS FLUSHES, WHICH WERE LONG AND SKINNY) ARE NOT RECOGNIZED BY OUR ALARIS IV PUMPS CORRECTLY, INSTEAD OF DETECTING A 3ML SYRINGE, THE PUMP ONLY DETECTS IT AS A 10ML SYRINGE. WHEN THESE NEW FLUSHES WERE PLACED IN OUR STORE ROOM, RNS WERE INSTRUCTED TO JUST RUN IT AS A 10CC FLUSH. IF THIS IS SELECTED, THE PUMP IS UNABLE TO DELIVER THE DESIRED VOLUME OF FLUSH TO THE PATIENT (IE: ENTER TO FLUSH 1ML, ONLY .6 IS DELIVERED). THIS NEGATIVELY IMPACTS OUR PATIENTS, ESPECIALLY THE SMALLEST BABIES. IF THE WHOLE FLUSH ISN'T DELIVERED, THEN MEDICATION IS STILL IN THE IV LINE AND THE PATIENT DOES NOT RECEIVE THEIR ENTIRE DOSE. SOME NURSES- MYSELF INCLUDED- ARE WORKING AROUND THIS ISSUE BY USING THE STERILE 10CC NS FLUSHES THAT THE PUMPS RECOGNIZE AND DELIVER THE CORRECT VOLUME, BUT COST M

  Patient problems: Underdose

  MAUDE report 8800270 ↗
• MalfunctionJun 24, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD POSIFLUSH¿ SP SYRINGE 3 ML HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306544, BATCH NO: 8353601. IT WAS REPORTED THAT THE OUTSIDE CARDBOARD BOX SAYS "HEPARIN" BUT THE WHITE BOXES INSIDE HAVE THE CORRECT LABELING OF THE SALINE SYRINGES. INJURIES OR ADVERSE EVENT: NO. ITEM: 306544. QUANTITY AFFECTED: 5 CS. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE BROWN CARDBOARD BOX SAYS HEPARIN, BUT THE WHITE BOXES ON THE INSIDE DON¿T. CUSTOMER WANTS TO KNOW IF THIS IS AN ISSUE. CUSTOMER DISPOSITION REQUEST: REPLACEMENT. WHITE BOXES ON THE INSIDE LOOKED LIKE THEY SHOULD SALINE FLUSH SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8727819 ↗
• MalfunctionMay 28, 2019Leak/Splash; Leak/Splash

  MATERIAL NO: 306544, BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE THE PRODUCT CREATES TOO MUCH PRESSURE WHEN ADMINISTERING MEDICINE AND CAUSES THE VEIN TO BURST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST HAD A CALL FROM A PHARMACY BUYER LOOKING FOR THE STATUS OF MATERIAL 306507, HOWEVER THIS ITEM IS DISCONTINUED AND REFERED HER TO THE SUBSTITUTE. SHE SAID THAT THE SUBSTITUTE, 306544, IS CAUSING ISSUES FOR NICU PATIENTS DID NOT WANT TO USE IT. I HAVE REFERRED TO SALES REP AS WELL. 306507 ¿ CUSTOMER USED TO USE. 306544 ¿ CUSTOMER REPORTED THAT THE MATERIAL CREATES TOO MUCH PRESSURE WHEN ADMINISTERING MEDICINE WHICH CAUSES THE VEIN TO BURST ON NICU PATIENTS.

  Patient problems: No Code Available

  MAUDE report 8647269 ↗
• MalfunctionDec 28, 2018Device Markings/Labelling Problem

  IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE THERE WAS AN ISSUE WITH LABEL CONTAINING A QR CODE INSTEAD OF A REGULAR BAR CODE.

  Patient problems: No Information

  MAUDE report 8203338 ↗
• MalfunctionDec 6, 2018Increase in Pressure

  IT WAS REPORTED THAT DURING USE OF THE BD POSIFLUSH¿ IV FLUSH PREFILLED SYRINGE 3 ML CAUSED ¿LINES TO BLOW BECAUSE OF THE HIGHER PRESSURE¿, WHEN HAND FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139255 ↗