BD PosiFlush 306553Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00382903065530), received between Dec 20, 2017 and Aug 26, 2026 — classified as 6 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (34 reports).

1 other recall cover devices cleared under the same FDA submission (K153481); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionJul 25, 2025Packaging Problem; Packaging Problem

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE THE ATTACHED NOTIFICATION IN REFERENCE TO MULTIPLE LOTS OF ITEM 306553. WHILE BEING UTILIZED ON THE PRODUCTION LINE, IT WAS NOTED THE LOTS 4256173, 5006316, AND 4250495 OF ITEM 306553 ALL HAD YELLOWING AND YELLOW SPOTS ON THE LABELS OF THE SYRINGES. EACH LOT FAILED SAMPLING. AS ALL LOTS IN HOUSE WERE AFFECTED BY THIS, MAI MADE THE DECISION TO SORT THE PRODUCT FOR USE. THE AMOUNT OF AFFECTED SYRINGES ARE LISTED BY LOT IN THE ATTACHED AND BELOW. PLEASE PROVIDE AN RTV FOR THESE COMPONENTS AS WE ARE UNABLE TO USE THEM. WE ARE HAPPY TO SEND SAMPLES IF YOU PROVIDE SHIPPING INFORMATION. THE ITEM, LOTS, POS, AND EACHES ARE ALL IN THE ATTACHED NOTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613193 ↗
• MalfunctionJul 14, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD POSIFLUSH-XS / SF FOREIGN MATTER IN THE PACKAGE SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE BEING UTILIZED IN PRODUCTION, IT WAS NOTED THAT 7 EACHES OF ITEM 306553, LOT 5023049 HAD DEBRIS VISIBLE IN THE SYRINGE AND SYRINGE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494932 ↗
• MalfunctionJul 1, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BD POSIFLUSH-XS / SF A TEAR IN THE TOP WEB (INVESTIGATION FINDING) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (IS NOT RELATED TO THE REPORTABLE EVENT SEE H10 FOR DEVICE EVALUATION FINDINGS): YELLOWING AND YELLOW SPOTS ON THE LABELS OF THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374830 ↗
• MalfunctionMay 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  04-JUNE-2024: BD QUESTION: PLEASE CONFIRM IF THE DEVICE WAS USED OR NOT USED ON THE PATIENT. IF USED ON A PATIENT CONFIRM NO HARM/SERIOUS INJURY OCCURRED. ANSWER: THE PRODUCT WAS USED IN SOME PATIENTS WITH THE EXPIRATION DATE CORRECTED ON OUR LABELING (WOULD HAVE BEEN CAPPED AT 365 DAYS ANYWAY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072450 ↗
• MalfunctionJan 29, 2025Material Fragmentation; Material Fragmentation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267411 ↗
• MalfunctionJan 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BD POSIFLUSH-XS / SF WAS DOUBLE PACKAGED WITH CONFLICTING LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER STATES THEY HAVE THE POSIFLUSH STERILE FIELD SALINE SYRINGE, REF (B)(4). A NURSE NOTICED THE SYRINGE WAS DOUBLE PACKAGED. THE FIRST PACKAGE IS A CLEAR PACKAGING WRAPPER THAT SAYS, "DO NOT PLACE SYRINGE ON STERILE FIELD"; THIS IS THEN PACKAGED IN A SECOND PLASTIPAK STYLE PACKAGING THAT SAYS "MAY BE USED ON STERILE FIELD USING PROPER ASEPTIC TECHNIQUE." THE NURSES WERE QUESTIONING WHICH IS CORRECT AND DO NOT WANT TO USE THE SYRINGE IN A STERILE FIELD IF IT IS NOT SAFE. CALLER WONDERING IF THIS SYRINGE IS SUPPOSED TO BE PACKAGED THIS WAY BECAUSE BOTH LABELS CONTRADICT EACH OTHER. ADDITIONAL INFORMATION: I DON¿T HAVE A DATE OF THE EVENT, AS I WAS FOLLOWING UP FOR SOMEONE ELSE. NO PHYSICAL SAMPLE AND NO ADVERSE EVENT TO MY KNOWLEDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163866 ↗
• MalfunctionNov 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791530 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT BD POSIFLUSH TIP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER NURSE HAD ACCESSED PATIENT PORT STERILELY, NURSE WENT TO FLUSH LINE WITH SALINE SYRINGE VIA STOPCOCK. AFTER FLUSHING NURSE WENT TO TWIST OFF FLUSH AND TIP OF FLUSH BROKE OFF STILL CONNECTED TO STOPCOCK. NURSE ABLE TO STERILELY REPLACE STOPCOCK AND CONTINUE PROCEDURE.¿ NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185642 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT IT WAS REPORTED THAT BD POSIFLUSH PLUNGER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WERE ABLE TO RECREATE THE MALFUNCTION WITH ADDITIONAL SYRINGES FROM THE SAME LOT. NURSE REPORTED THAT WHEN SHE WAS DRAWING LABS OUT OF PT CHEMO PORT, THE 10CC FLUSH PLUNGER BROKE WHILE SHE WAS PULLING BACK ON THE SYRINGE TO CHECK FOR BLOOD RETURN. MULTIPLE NURSES THEN CAME FORWARD SAYING THIS HAS BEEN HAPPENING. ADDITIONAL INFO: WE WERE ABLE TO MAKE THE MALFUNCTION OCCUR AROUND 2 OUT OF EVERY 5 SYRINGES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128336 ↗
• MalfunctionFeb 20, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743523 ↗
• MalfunctionNov 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED ON 22-NOV-2023. THIS IS THE BARCODE SCAN RESULTS. ]D2010038290306553017310326103110715. THE PORTION IN BOLD AND UNDERLINE IS THE DATE STAMP. WE FEEL THIS DATE IS FORMATTED YYMMDD WHILE WE¿RE EXPECTING IT TO BE DDMMYY. THUS, THE EXPIRATION DATE IS PARSING INCORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171315 ↗
• MalfunctionNov 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED ON 22-NOV-2023. THIS IS THE BARCODE SCAN RESULTS. ]D2010038290306553017310326103110715. THE PORTION IN BOLD AND UNDERLINE IS THE DATE STAMP. WE FEEL THIS DATE IS FORMATTED YYMMDD WHILE WE¿RE EXPECTING IT TO BE DDMMYY. THUS, THE EXPIRATION DATE IS PARSING INCORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171274 ↗
• MalfunctionSep 15, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD PRE-FILLED SALINE SYRINGE LABEL INFORMATION WAS MISSING. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED PREFILLED SYRINGE DID NOT HAVE LABEL ON IT WAS A BLANK SYRINGE UNABLE TO IDENTIFY WHAT IT WAS IN THE PACK. NO GRADUATION MARKINGS EITHER. ANOTHER SYRINGE WAS FOUND WITH TWO LABELS SO IT APPEARS IT WAS A MISPRINT WITH THE SAME LOT, REF AND EXPIRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757796 ↗
• MalfunctionSep 15, 2023Volume Accuracy Problem; Device Markings/Labelling Problem; Volume Accuracy Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE THE BD PRE-FILLED SALINE SYRINGE SCALE MARKINGS WERE MISSING. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED PREFILLED SYRINGE DID NOT HAVE LABEL ON IT WAS A BLANK SYRINGE UNABLE TO IDENTIFY WHAT IT WAS IN THE PACK. NO GRADUATION MARKINGS EITHER. ANOTHER SYRINGE WAS FOUND WITH TWO LABELS SO IT APPEARS IT WAS A MISPRINT WITH THE SAME LOT, REF AND EXPIRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757783 ↗
• MalfunctionAug 2, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE PACKAGING TORE WHILE OPENING AND LEFT PAPER SHARDS IN THE STERILE FIELD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THE CHADS FROM THE PERFORATION ARE FLAKING ONTO THE STERILE FIELD. WHEN THEY'RE OPENED FROM PAPER PACK, SOME OF THE PAPER SEEMS TO BE FLAKING OFF ONTO THE STERILE FIELD. THEY ARE NOT SURE THE EXACT AMOUNT SO FAR THAT HAVE HAD THE ISSUE... -IS THERE ANY ADVERSE EVENT OCCURRED? NO .-IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446225 ↗
• MalfunctionAug 2, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE PACKAGING TORE WHILE OPENING AND LEFT PAPER SHARDS IN THE STERILE FIELD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THE CHADS FROM THE PERFORATION ARE FLAKING ONTO THE STERILE FIELD. WHEN THEY'RE OPENED FROM PAPER PACK, SOME OF THE PAPER SEEMS TO BE FLAKING OFF ONTO THE STERILE FIELD. THEY ARE NOT SURE THE EXACT AMOUNT SO FAR THAT HAVE HAD THE ISSUE. IS THERE ANY ADVERSE EVENT OCCURRED? NO IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442493 ↗
• MalfunctionJul 13, 2023Missing Information; Missing Information

  IT WAS REPORTED THERE WERE 3 BD FLUSH EXT STERILE SYRINGE'S MISSING ALL PRINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT IS REPORTED THAT A NUMBER OF MESSAGES ABOUT SYRINGES (306553) MISSING ALL PRINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321658 ↗
• MalfunctionJan 26, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SF SALINE SYRINGE WAS "MELTED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A MELTED SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251427 ↗
• MalfunctionNov 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT RED FOREIGN MATTER WAS FOUND INSIDE 2 BD POSIFLUSH¿ SF SALINE SYRINGES DURING A WORK ORDER CREATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOVERY OF RED SUBSTANCE / DEBRIS/ CONTAMINATION WITHIN 2 EACH 306553 SALINE SYRINGE 10ML LOT 2110682. OUR ASSEMBLY TEAM FOUND RED DEBRIS / CONTAMINATION WITHIN THE SYRINGE PACK AND SEAL OF 2 EACH DURING WORK ORDER CREATION. QA APPROVED THE REMAINDER OF LOT 2110682 VIA ANSI SAMPLING, NO FURTHER DEBRIS WAS FOUND, THERE IS NO MATERIAL ON HOLD.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825360 ↗
• MalfunctionSep 23, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT 5 BD POSIFLUSH¿ SF SALINE SYRINGE HAD DIRTY PACKAGING INCLUDED THROUGH THE STERILE BARRIER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : WE HAVE SF BD 10ML SYRINGES THAT HAS SOMETHING NON-STERILE PACKAGED WITH IT (SOME SORT OF DIRTY PACKAGING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473979 ↗
• MalfunctionMay 9, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT PRIOR TO USING A BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10ML SYRINGE, THE SYRINGE BARREL WAS DENTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STERILE SYRINGE IN VAD ACCESS KIT WAS DENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336481 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153481. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2020 · Apr 16, 2020 · Terminated
  BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535