BD PosiFlush 306424Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00382903064243), received between May 16, 2018 and Dec 3, 2024 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Packaging Problem; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832327 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER RESPONSE ON MARCH 27, 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? WE DON¿T HAVE AN EXACT DATE. PATIENT REPORTED TO US ON (B)(6) 2024 THEY HAD A RARE INFECTION IN HER PORT, LECLERCIA ADECARBOXYLATA. THIS HAS PREVIOUSLY BEEN ASSOCIATED WITH CONTAMINATED HEPARIN. PATIENT BELIEVED INFECTION / INITIAL EXPOSURE HAPPENED ~ 9 WEEKS AGO. I WAS ASKED TO REACH OUT TO BD TO SEE IF THERE HAD BEEN ANY OTHER REPORTS OF THIS INFECTION RECENTLY. 2. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO. 3. WAS THERE ANY MEDICAL INTERVENTION REQUIRED? ENTIRE PORT REMOVED; TX WITH VANC/ZOSYN; SENT HOME ON LEVAQUIN. 4. WHAT WAS THE PATIENT OUTCOME FROM THE INFECTION? COULD YOU PLEASE PROVIDE FURTHER DESCRIPTION. ENTIRE PORT REMOVED; TX WITH VANC/ZOSYN; SENT HOME ON LEVAQUIN.

  Patient problems: Bacteremia

  MAUDE report 18993051 ↗
• MalfunctionMar 25, 2024Missing Information; Missing Information

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 306424 BATCH #: 329951N IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT HAD NO DEMARCATIONS TO INDICATE DOSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. U.S. FOOD & DRUG ADMINISTRATION] HEPARIN 100 UNIT/ML IN SEALED PACKAGING HAD NO DEMARCATIONS TO INDICATE DOSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968213 ↗
• MalfunctionJun 13, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118439 ↗
• MalfunctionApr 8, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TIP CAP WAS FOUND SEPARATED FROM THE BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE INSIDE THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YELLOW CAP CAME OFF OF A SYRINGE (INSIDE INTACT PACKAGING) OF HEPARIN LOCK... NO PATIENT HARM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705163 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT THE BD 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PLUGER ROD WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE CAME WITH A DEFECTIVE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587874 ↗
• MalfunctionJun 22, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT TWO 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML DOES NOT HAVE THE MANUFACTURER LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT RECEIVED A SEALED BOX OF HEPARIN 100U/ML FLUSHES WHEREIN 2 FLUSHES HAD NOT MANUFACTURER LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776761 ↗
• MalfunctionJun 1, 2022Missing Information; Missing Information

  IT WAS REPORTED WHILE USING BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE 2 DIFFERENT SYRINGES DID NOT HAVE LABELS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER FOUND 2 SYRINGES WITHOUT LABELS. A NURSE IN THE PATIENT'S HOME REPORTED 2 UNLABELED SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14564959 ↗
• MalfunctionSep 10, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SYRINGE 5ML HEPARIN 100 UNIT HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD JUST LIKE TO BRING TO YOUR ATTENTION THAT WE HAVE RECEIVED SOME SYRINGES OF HEPARIN LOCK FLUSH AND WE NOTICED THAT 1 OF THE SYRINGES WAS MISSING A LABEL AS WELL AS ANY CALIBRATION THAT IS USUALLY PRINTED ON THE PHYSICAL SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455293 ↗
• MalfunctionSep 10, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SYRINGE 5ML HEPARIN 100 UNIT HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD JUST LIKE TO BRING TO YOUR ATTENTION THAT WE HAVE RECEIVED SOME SYRINGES OF HEPARIN LOCK FLUSH AND WE NOTICED THAT 1 OF THE SYRINGES WAS MISSING A LABEL AS WELL AS ANY CALIBRATION THAT IS USUALLY PRINTED ON THE PHYSICAL SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455195 ↗
• MalfunctionFeb 23, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 5ML HEPARIN 100 UNIT WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS WORKED WITH THE HEPARIN LOCK FLUSH SOLUTION USP PRODUCT IN SEVERAL PRESENTATIONS FOR A LONG TIME WITHOUT OBSERVATIONS. NOW IN PARTICULAR HAS RECEIVED REPORT OF BATCH (B)(4) OF THE 100 UNITS/ML 5ML PRESENTATION, THAT IN 3 PATIENTS IT WAS NOT OBTAINED THE EXPECTED PERMEABILITY, THAT'S WHY THEY SENT AN E-MAIL TO FIND OUT IF THERE WAS ANY DEVIATION OF THE CONCENTRATION IN THE BATCH OF THIS MATTER, OR IF THERE WAS ANOTHER REPORT FROM OTHER CUSTOMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11369479 ↗
• MalfunctionSep 26, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE 2D BARCODE ON THE SYRINGE 5ML HEPARIN 100 UNIT LABEL WAS OBSERVED TO BE MISSING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 100ML HEPARIN FLUSH SYRINGE MISSING 2D BARCODE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9124009 ↗
• MalfunctionAug 26, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT HAS BEEN REPORTED THAT THE SYRINGE 5ML HEPARIN 100 UNIT HAS BEEN FOUND MISSING LABELS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306424, BATCH NO. UNKNOWN. IT WAS REPORTED THAT HEPARIN FLUSH SYRINGE WAS FOUND WITHOUT LABELING. PER EMAIL: A UNIT RN BROUGHT TO PHARMACY¿S ATTENTION A HEPARIN FLUSH WITHOUT ANY IDENTIFICATION. SINCE THEY ARE LOADED BY BOX, ITS SISTER SYRINGES BELONG TO LOT: 827575N, EXP: 9/30/2020. THE NURSES ALSO COMMENTED THAT THIS IS NOT THE FIRST ONE THEY HAVE FOUND WITHOUT A LABEL, ONLY THE FIRST BROUGHT TO PHARMACY¿S ATTENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931509 ↗
• MalfunctionAug 26, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL NO. 306424, BATCH NO. 827575N. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE 5ML HEPARIN THE HEPARIN FLUSH SYRINGE WAS MISSING THE LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A UNIT RN BROUGHT TO THE PHARMACY¿S ATTENTION A HEPARIN FLUSH WITHOUT ANY IDENTIFICATION. SINCE THEY ARE LOADED BY BOX, ITS SISTER SYRINGES BELONG TO LOT: 827575N, EXP: 9/30/2020. THE NURSES ALSO COMMENTED THAT THIS IS NOT THE FIRST ONE THEY HAVE FOUND WITHOUT A LABEL, ONLY THE FIRST BROUGHT TO PHARMACY¿S ATTENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931027 ↗
• MalfunctionAug 16, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABEL ERROR WAS FOUND BEFORE USE WITH A SYRINGE 5ML HEPARIN 100 UNIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER CONVERTED FROM STANDARD FLUSH TO BD POSIFLUSH SYRINGES AND HEPARIN - AN ERROR IN THE CROSS REFERENCE CAUSED THE CUSTOMER TO ORDER 100UPS UNITS/ML INSTEAD OF 10UPS UNITS/ML. PRODUCT MADE IT ALL THE WAY TO THE END USED FORTUNATELY, THE NURSE RECOGNIZED THE COLOR CODING AND QUESTIONED THIS SYRINGE TO AVOID ADVERSE PATIENT OUTCOME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903219 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT ADMITTED TO HOSPITAL DUE TO SEVER THROMBOSIS AFTER BEING TREATED WITH A BD SYRINGE 5ML HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED AND STATED THAT A PATIENT WAS TREATED WITH A BD POSIFLUSH ((B)(6) 2019) HAS BEEN ADMITTED TO THE HOSPITAL TODAY ((B)(6) 2019) WITH SEVERE THROMBOSIS LEUKAEMIA. PT'S PLATELETS YESTERDAY WERE NORMAL AND AS AT TIME OF ADMISSION IS 2. CUSTOMER HAS ISOLATED REMAINING PRODUCTS FROM THIS LOT AND HAS REPRESENTATIVE SAMPLES TO SEND.

  Patient problems: Thrombosis

  MAUDE report 8832803 ↗
• MalfunctionMar 19, 2019Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A BD¿ SYRINGE 5ML HEPARIN 100 UNIT DID NOT HAVE BARCODES ON THEM CUSTOMER¿S VERBATIM: ¿ HEALTH PROFESSIONAL CALLED TO REPORT THAT THEY FOUND TWO BOXES WHERE THE SYRINGE PACKAGES DID NOT HAVE BARCODE SO THEY ARE UNABLE TO SCAN THEM INTO THEIR INVENTORY. LOT 827576N FOUND "THE OTHER DAY" AND LOT 827573N FOUND "TODAY". SHE MIGHT BE ABLE TO PROVIDE PHOTOS. SHE WONDERS IF THIS IS A PERMANENT CHANGE. NO PATIENT INVOLVEMENT, BEFORE USE.¿

  Patient problems: No Patient Involvement

  MAUDE report 8431931 ↗
• MalfunctionMar 18, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD SYRINGE¿ 5ML HEPARIN 100 UNIT PACKAGES DO NOT HAVE BARCODES ON THEM. VERBATIM: HEALTH PROFESSIONAL CALLED TO REPORT THAT THEY FOUND TWO BOXES WHERE THE SYRINGE PACKAGES DID NOT HAVE BARCODE SO THEY ARE UNABLE TO SCAN THEM INTO THEIR INVENTORY. LOT 827576N FOUND "THE OTHER DAY" AND LOT 827573N FOUND "TODAY". SHE MIGHT BE ABLE TO PROVIDE PHOTOS. SHE WONDERS IF THIS IS A PERMANENT CHANGE. NO PATIENT INVOLVEMENT, BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 8429466 ↗
• MalfunctionNov 26, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE CRACKED DURING USE AND LEAKED MEDICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104218 ↗
• InjuryJul 12, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A CUSTOMER WAS DIAGNOSED WITH SEPSIS THREE TIMES AND WENT INTO SEPTIC SHOCK. THE PATIENT FELL ILL ON (B)(6) 2018 WAS ADMITTED INTO ICU ON (B)(6) 2018 FOR FIVE DAYS. INFECTION WAS CLEARED EACH TIME AND LINE WAS REPLACED. BLOOD CULTURES TESTED (B)(6) FOR SERRATIA MARCESCENS FOR THE THIRD TIME WITHIN TWO MONTHS SINCE (B)(6) 2018. THE PATIENT ASSOCIATED A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5 ML WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVE

  Patient problems: Septic Shock; Unspecified Infection

  MAUDE report 7684414 ↗
• InjuryMay 31, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED NAUSEA/ VOMITING, CLAMMY PALE CHILLS AND LOW FEVER WHILE USING THE BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE. FOUND DURING USE. THE CUSTOMER CONSULTED WITH HIS PHYSICIAN DR (B)(6) AND WAS GIVEN NAUSEA MEDICATION AND INSTRUCTED TO GO TO THE EMERGENCY ROOM IF SYMPTOMS GET WORSE.

  Patient problems: Alteration In Body Temperature; Fever; Nausea; Vomiting

  MAUDE report 7557848 ↗
• InjuryMay 16, 2018Patient-Device Incompatibility

  ¿IT WAS REPORTED THAT ON TWO OCCASIONS ((B)(6)), AFTER 30 MINUTES OF PUSHING IV SALINE, PATIENT EXPERIENCED A SEVERE REACTION (COUGHING, COULDN'T BREATHE, COLD SWEATS). PATIENT ALSO USED HEPARIN FLUSH BUT THINKS THE ISSUE WAS FROM THE SALINE MORE SO THAN THE HEPARIN. PATIENT WENT TO THE ER ON BOTH OCCASIONS AND WAS TOLD THAT NOTHING WAS ABLE TO BE DETERMINED. ER CHECKED THE PATIENT'S LUNGS, CHECKED FOR EMBOLISM, ETC.¿ THERE WAS NO ADDITIONAL SPECIFIC INFORMATION ON THE MEDICAL INTERVENTIONS RECEIVED.

  Patient problems: Reaction; Respiratory Distress; Sweating

  MAUDE report 7519640 ↗
• InjuryMay 16, 2018Patient-Device Incompatibility

  ¿IT WAS REPORTED THAT ON TWO OCCASIONS ((B)(6)), AFTER 30 MINUTES OF PUSHING IV SALINE, PATIENT EXPERIENCED A SEVERE REACTION (COUGHING, COULDN'T BREATHE, COLD SWEATS). PATIENT ALSO USED HEPARIN FLUSH BUT THINKS THE ISSUE WAS FROM THE SALINE MORE SO THAN THE HEPARIN. PATIENT WENT TO THE ER ON BOTH OCCASIONS AND WAS TOLD THAT NOTHING WAS ABLE TO BE DETERMINED. ER CHECKED THE PATIENT'S LUNGS, CHECKED FOR EMBOLISM, ETC.¿ THERE WAS NO ADDITIONAL SPECIFIC INFORMATION ON THE MEDICAL INTERVENTIONS RECEIVED.

  Patient problems: Reaction; Respiratory Distress; Sweating

  MAUDE report 7519613 ↗