BD PosiFlush™ 306499Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00382903064991), received between Apr 29, 2019 and Sep 17, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (28 reports).

3 other recalls cover devices cleared under the same FDA submission (K161552); they may or may not involve this specific model.

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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 10, 2026Contamination

  IT WAS REPORTED, SYRINGE 10ML SHORT PR SALINE 10ML FILL, CONTAMINATED. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT BELOW IS BEING REPORTED BY THE CUSTOMER AS CONTAMINATED. PLEASE ADVISE DISPOSITION. NO REPLACEMENTS ARE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782311 ↗
• MalfunctionJun 26, 2026Infusion or Flow Problem

  IT WAS REPORTED, SYRINGE 10ML SHORT PR SALINE 10ML FILL, OCCLUSION ALARM WITH PUMP DURING USE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE PUMP ALARMED FOR AN OCCLUSION DURING USE WITH A BD POSIFLUSH SALINE PREFILLED SYRINGE, WHICH IS CURRENTLY NOT COMPATIBLE WITH THE ALARIS SYRINGE PUMP. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE INITIAL REPORT. THERE WAS NO INFORMATION TO INDICATE PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635221 ↗
• MalfunctionJun 16, 2026Contamination

  IT WAS REPORTED, SYRINGE 10ML SHORT PR SALINE, FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION AT THE TIP OF SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521771 ↗
• MalfunctionAug 13, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT IS REPORTED CRACKED SYRINGE. EVENT DESCRIPTION: MATERIAL#: 306499, BATCH#: 5077095. WAS PREPARING A TRIFUSE TO DRAW LABS AND ONE OF THE NS FLUSHES CRACKED DOWN THE SIDE AND LEAKED. THE DEVICE WAS NEVER CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794172 ↗
• MalfunctionJul 24, 2025Crack; Crack

  DESCRIPTION: CRACKED SYRINGE EVENT DETAILS: MATERIAL # 306499, BATCH # 5077095. WHILE ATTEMPTING TO FLUSH A PICC LINE, THE FLUSH SYRINGE CRACKED. ALL CLAMPS WERE OPEN. NO AIR GOT IN TO LINE, BUT IT COULD HAVE. WAS THERE INJURY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588916 ↗
• MalfunctionJul 7, 2025Defective Component; Defective Component

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER THAT STERILE SALINE SYRINGES WITH MALFUNCTIONING PLUNGERS. VERBATIM: THERE WAS AN IR PLACED A FEW WEEKS BACK ABOUT STERILE SALINE SYRINGES WITH MALFUNCTIONING PLUNGERS. AT THAT TIME, I SENT DOWN THE PRODUCT. WE DO HAVE ANOTHER SYRINGE THAT HAD THE SAME ISSUE THIS MORNING AND I HAVE THAT PRODUCT AS WELL. THE CLEAR PACKAGE THAT THE SALINE FLUSHES DON¿T HAVE ANYTHING ON THE PACKAGE. ADDITIONAL INFORMATION THE NURSE WAS USING A STERILE SALINE 10CC FLUSH TO DRAW BACK BLOOD FROM A CENTRAL LINE AFTER FLUSHING THE LINE WITH WATER. AS SHE WAS PULLING BACK, SHE FELT A LOT OF PRESSURE, AND THEN SUDDENLY THE BLACK PIECE OF RUBBER THAT ATTACHES TO THE PLUNGER OF THE SYRINGE CAME OFF AND THE SUCTION MECHANISM OF DRAWING BACK WAS DISENGAGED. THERE WAS NO HARM TO THE PATIENT. I AM UNSURE OF THE DATE OF THE LAST EVENT, I APOLOGIZE. IT WAS NOT REPORTED TO BD BUT IT WAS A SIMILAR SITUATION WHERE THE SUCTION MECHANISM WAS DISENGAGED WHEN DRAWING BACK WITH THE PLUNGER TO GET BLOOD OFF A LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412803 ↗
• MalfunctionJul 7, 2025Defective Component; Defective Component

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER THAT STERILE SALINE SYRINGES WITH MALFUNCTIONING PLUNGERS. MATERIAL # 306499 BATCH # 5077095. THERE WAS AN IR PLACED A FEW WEEKS BACK ABOUT STERILE SALINE SYRINGES WITH MALFUNCTIONING PLUNGERS. AT THAT TIME, I SENT DOWN THE PRODUCT. WE DO HAVE ANOTHER SYRINGE THAT HAD THE SAME ISSUE THIS MORNING AND I HAVE THAT PRODUCT AS WELL. THE CLEAR PACKAGE THAT THE SALINE FLUSHES DON¿T HAVE ANYTHING ON THE PACKAGE. ADDITIONAL INFORMATION THE NURSE WAS USING A STERILE SALINE 10CC FLUSH TO DRAW BACK BLOOD FROM A CENTRAL LINE AFTER FLUSHING THE LINE WITH WATER. AS SHE WAS PULLING BACK SHE FELT A LOT OF PRESSURE, AND THEN SUDDENLY THE BLACK PIECE OF RUBBER THAT ATTACHES TO THE PLUNGER OF THE SYRINGE CAME OFF AND THE SUCTION MECHANISM OF DRAWING BACK WAS DISENGAGED. THERE WAS NO HARM TO THE PATIENT. I AM UNSURE OF THE DATE OF THE LAST EVENT, I APOLOGIZE. IT WAS NOT REPORTED TO BD BUT IT WAS A SIMILAR SITUATION WHERE THE SUCTION MECHANISM WAS DISENGAGED WHEN DRAWING BACK WITH THE PLUNGER TO GET BLOOD OFF A LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412783 ↗
• MalfunctionJan 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21218720 ↗
• MalfunctionJan 7, 2022Inappropriate Audible Prompt/Feedback; Defective Component; Inappropriate Audible Prompt/Feedback; Defective Component

  IT WAS REPORTED THAT AT LEAST 1 BD POSIFLUSH¿ SF SALINE SYRINGE EACH FROM LOTS 1133341 AND 1133339 HAD DIFFICULT PLUNGER MOVEMENT DURING THEIR FLUSHES FOLLOWING MEDICATION DOSING, CAUSING THEIR SYRINGE PUMPS TO ALARM FOR OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY ARE STATING THAT THE SALINE FLUSH FOLLOWING ANY MEDICATION DOSE KEEPS BEEPING OCCLUSION ON THE MED PUMP. WE HAVE RECEIVED 4 INCIDENTS OF THIS TODAY WITH TWO DIFFERENT LOT NUMBERS AFFECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196784 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML SHORT PR SALINE 10ML FILL PLUNGER DETACHED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WHEN NURSES ARE USING THE NEW SYRINGES TO DRAW BLOOD, AS THEY PULL BACK ON THE PLUNGER IT BECOMES DETACHED FROM THE SYRINGE. THIS HAPPENS WITH MULTIPLE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426056 ↗
• MalfunctionJan 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPPER SEPARATED FROM THE BD POSIFLUSH¿ SF SALINE SYRINGE PLUNGER WHILE FLUSHING A PICC LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUSHING A PICC LINE AND DRAWING FOR WASTE WHEN A PLUNGER BECAME DISCONNECTED FROM INSIDE THE SYRINGE. NO RESISTANCE PRIOR TO OCCURRENCE. NEW SYRING CONNECTED TO COMPLETE THE FLUSHING FOR LAB COLLECTION. SAME THING OCCURRED TO TWO OF THE SAME (LOT) SYRINGES. CUSTOMER STATED THERE WAS NO ISSUE REPORTED REGARDING THE PICC."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11115037 ↗
• MalfunctionMar 24, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT THE RUBBER STOPPER SEPARATED FROM THE BD POSIFLUSH¿ SF SALINE SYRINGE PLUNGER DURING USE, CREATING "PRESSURE" IN THE ROD WHEN TRYING TO MOVE IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAD AN UNUSUAL ISSUE THAT WAS BROUGHT TO MY ATTENTION THIS WEEK BY SOME TREATMENT ROOM STAFF. APPARENTLY WHEN ASKING OTHER NURSES ON THE OTHER FLOORS, THIS HAPPENS WITH DIFFICULT PICC'S THAT THEY HAVE TO FLUSH AND MANIPULATE AND THERE IS PRESSURE WHEN WORKING WITH THEM. APPARENTLY THE BLACK RUBBER PLUNGER PART COMES DETACHED FROM THE PLASTIC PLUNGER. THEY ALSO MENTIONED THAT LATELY, THE NS SYRINGES ARE DIFFERENT AND THIS HAPPENED JUST LATELY." "THE STAFF EXPLAINED THAT THE PLASTIC SYRINGE PLUNGER ROD WOULD SEPARATE FROM THE RUBBER STOPPER IF THEY HAD A ¿DIFFICULT PICC¿ WHERE THEY HAD TO DO A LOT OF ¿PUSHING AND PULLING¿ AND IF THEY WERE DRAWING A WASTE SYRINGE OF BLOOD FROM A LINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9875177 ↗
• MalfunctionMar 14, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRS 10 ML FIL SALINE SHORTLENGTH PLUNGER RODS EXPERIENCED SYRINGE VOLUMETRIC ACCURACY ISSUES WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306499 BATCH NO: 9002664. CUSTOMER STATED THAT THE SYRINGE IS OFF BY .4 - .6ML WHEN ASPIRATED WITH MEDICATION. HE REPORTED THIS HAPPENING BEFORE BUT SAID NOTHING CAME OF IT. HE STATES THIS HAS BEEN HAPPENING SINCE NOVEMBER 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9832849 ↗
• MalfunctionMar 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD EXPERIENCED STOPPER SEPARATION FROM THE PLUNGER. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306499 BATCH NO.: 9018605. VERBATIM: I'M NOT SURE WHAT IS HAPPENING AT BD WITH THE MANUFACTURING OF THEIR SYRINGES BUT WE ARE NOW GETTING REPORTS OF THE FLUSHES HAVING PROBLEMS. THE BLACK PIECE IS COMING OFF OF THE PLUNGER. THIS IS THE SAME PROBLEM REPORTED WITH THE 20ML SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9791589 ↗
• MalfunctionFeb 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYR 10 ML FIL SALINE SHORT LENGTH PLUNGER ROD SEPARATED FROM THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: I WAS ADMINISTERING CHEMO AND I WENT TO CHECK BLOOD RETURN WITH THE SYRINGE AND WHEN I PULLED BACK THE PLUNGER DISCONNECTED FROM THE SYRINGE. I KNOW THIS HAS BEEN A PROBLEM WITH SYRINGES BUT THE FLUSH WAS STILL IN TACT (THE WATER DIDN'T FALL OUT) BUT PART OF THE PLUNGER DID. I SAVED IT. THERE IS ACTUALLY NO CHEMO IN THE SYRINGE. THIS WAS JUST USED ON A PATIENT WHO WAS RECEIVING CHEMO. THE DEFECTIVE PRODUCT HAS BEEN SAVED FOR EVALUATION. PLEASE ADVISE ON THE NEXT STEPS AND IF YOU WOULD LIKE US TO SEND YOU THE PRODUCT.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9723293 ↗
• MalfunctionFeb 18, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE BARCODE SCANNED AS "HEPARIN" INSTEAD OF "NORMAL SALINE" BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THE PRODUCT IS SCANNING AS HEPARIN BUT THE CATALOG STATES THE PRODUCT IS NORMAL SALINE. VERBATIM: UPON SCANNING, WE RECEIVED A WARNING STATING THE BARCODE DOES NOT MATCH THE APPROPRIATE PRODUCT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9723255 ↗
• MalfunctionNov 8, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT THE STOPPER IN THE BD POSIFLUSH¿ SF SALINE SYRINGE WAS "THICKER" AT THE END, AND THE PRE-FILLED SOLUTION WAS "ABOUT .4 ML'S" UNDER SPECIFICATION. ALL DEFECTS WERE FOUND DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ISSUE IS THAT WE HAVE A NEW VERSION OF THE POSIFLUSH SYRINGE WHERE THE RUBBER STOPPER AT THE END IS THICKER THAN THE PREVIOUS ONE, AND I WAS WONDERING IF THE DIMENSIONS ON THE NEW POSIFLUSH SYRINGE ARE DIFFERENT THAN THE OLD MODEL. BECAUSE THE ONES FROM THE NEW LOT ARE READING ABOUT .4 ML'S UNDER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295924 ↗
• MalfunctionNov 7, 2019Leak/Splash; Leak/Splash

  MATERIAL NO.: 306499 BATCH NO.: 9002664. IT WAS REPORTED THAT DURING USE OF THE BD POSIFLUSH¿ SF SALINE SYRINGE THE SYRINGE TIP BROKE OFF IN THE STOP COCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SYRINGE TIP BROKE OFF IN THE STOP COCK. I DON¿T THINK IT HAD ANYTHING TO DO WITH THE AMOUNT OF FORCE I WAS USING, NO MORE FORCE USED THAN NORMAL. THIS OCCURRED AFTER THE ARTERIAL LINE CHANGE AND WHEN WE WENT TO REMOVE THE SYRINGE FROM THE STOPCOCK AFTER DRAWING LABS ON AN OPEN SYSTEM ARTERIAL LINE. I WENT TO EXCHANGE THE SYRINGE TO PUT AN EMPTY ONE ON TO DRAW MY LABS. WHEN TWISTING OFF THE FULL NS SYRINGE THE TIP BROKE OFF. I WAS NOT DRAWING BACK AT THE TIME SIMPLY TWISTING OFF THE SYRINGE. HOPE THIS HELPS. I HAVE AN ARTERIAL LINE FREQUENTLY AND THIS HAD NEVER HAPPENED BEFORE.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9290247 ↗
• MalfunctionNov 4, 2019Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED WITH SYR 10 ML FIL SALINE SHORT LENGTH PLUNGER RODS ON THE MINI PUMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE 10ML FLUSHES ARE CAUSING OCCLUSION ALARMS ON MINI PUMPS. ONE OF OUR STAFF JUST BROUGHT TO MY ATTENTION THAT THE NEW 10ML FLUSHES ARE READING OCCLUSION ON THE MINI PUMPS, AS EXPERIENCED BY AT LEAST 3 PEOPLE. I DIDN'T KNOW IF YOU HAD THIS BROUGHT TO YOUR ATTENTION, OR IF THERE IS ANOTHER AVENUE THAT I SHOULD BE EXPLORING TO INVESTIGATE THIS. I ASKED THE NURSE TO FILL OUT A PSOR AS WELL SO THAT IT CAN BE TRACKED IF THIS IS AN ONGOING ISSUE. PLEASE LET ME KNOW IF YOU HAVE ALREADY HEARD OF THIS OR IF YOU NEED MORE INFORMATION. THANK YOU, PER EMAIL: I MET WITH THE UNIT DIRECTOR AND ALL 10 STAFF MEMBERS TODAY. OUT OF THESE STAFF MEMBERS, ONLY ONE PERSON, SHARED THAT HE HAS AN OCCASIONAL ISSUE WITH THE MEDFUSION 4000 PUMP PRESSURE ALARMING WHEN HE USES THE ITEM #306499 ON THE PUMP AFTER DILUTING MEDICATION IN THE FLUSH SYRINGE FIRST. HE STATES THAT HE PURGES SOME OF THE FLUSH FROM THE FLUSH SYRINGE, DRAWS UP SOME MEDICATION (BENADRYL WAS AN EXAMPLE HE USED) AND INJECTS THE MEDICATION I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9274140 ↗
• MalfunctionOct 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE FLUSHING CENTRAL LINE, PULLED BACK PLUNGER TO CHECK FOR BLOOD RETURN AND THE STOPPER SEPARATED FROM THE PLUNGER WITH A BD SYRINGE 10ML SHORT PR SALINE 10ML FILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS FLUSHING CENTRAL LINE WITH 10ML NS FLUSH AND PULLING BACK TO CHECK FOR A BLOOD RETURN. WHILE PULLING BACK, THE PLUNGER DISCONNECTED FROM THE BLACK STOPPER, MAINTAINING THE SALINE IN THE SYRINGE BUT NOT ALLOWING RN TO CONTINUE FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9256009 ↗
• MalfunctionOct 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE STOPPER SEPARATED FROM THE PLUNGER DURING USE WHILE PULLING BACK ON THE SYRINGE TO GET BLOOD RETURN. THE PRODUCT WAS FLUSHED PRIOR TO USE WITH A "10CC SYRINGE". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN WAS DRAWING BLOOD. FLUSHED LINE PRIOR TO DRAW WITH 10CC SYRINGE. PULLED BACK ON SYRINGE TO GET BLOOD RETURN & PLUNGER CAME APART FROM STOPPER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250945 ↗
• MalfunctionOct 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE THE STOPPER SEPARATED FROM THE PLUNGER WITH A BD SYRINGE 10ML SHORT PR SALINE 10ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS DRAWING BLOOD. FLUSHED LINE PRIOR TO DRAW WITH 10CC SYRINGE. PULLED BACK ON SYRINGE TO GET BLOOD RETURN AND PLUNGER CAME APART FROM STOPPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250053 ↗
• MalfunctionOct 17, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT ONE SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD HAS BEEN FOUND WITH STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PLUNGER ROD SEPARATED FROM THE STOPPER AND PULLED OUT OF THE SYRINGE. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: DATE OF OCCURRENCE: (B)(6) 2019. PRODUCT ITEM NUMBER: 306499. LOT NUMBER: 9002663. DESCRIPTION: ¿PLUNGER PULLED OUT OF FLUSH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9203746 ↗
• MalfunctionOct 14, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD POSIFLUSH¿ PRE-FILLED NORMAL SALINE SYRINGE PUMP WOULD NOT INFUSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306499 BATCH NO: UNKNOWN. IT WAS REPORTED THAT PUMP KEPT ALARMING "OCCLUDED" AND WOULD NOT INFUSE. COMPLAINT: WHEN TRYING TO INFUSE DEXAMETHASONE (DILUTED IN 10CC FLUSH) PUMP KEPT ALARMING "OCCLUDED" AND WOULD NOT INFUSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9186200 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161552. One submission often covers many models, so check the product and lot details in each record.

• Z-0736-2024 · Nov 16, 2023 · Open, Classified
  PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
• Z-0500-2020 · Oct 14, 2019 · Terminated
  BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
• Z-0499-2020 · Oct 14, 2019 · Terminated
  BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547