BD PosiFlush 306513Recalls & reported problems
Becton, Dickinson And Company · HEPARIN 100UL 5ML FILL IN 10ML SYRINGE · Class 2
All models of BD PosiFlush (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 4
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903065134), received between Apr 23, 2018 and May 7, 2020 — classified as 4 deaths, 7 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (8 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
Device problems
- Microbial Contamination of Device8
- Nonstandard Device6
- Adverse Event Without Identified Device or Use Problem3
- Device Markings/Labelling Problem2
- Device Contamination with Chemical or Other Material1
Patient problems
- Bacterial Infection7
- Death3
- No Known Impact Or Consequence To Patient3
- Unspecified Infection3
- Pain2
- Complaint, Ill-Defined1
- Constipation1
- Diarrhea1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE HEPARIN 100UL 5ML FILL IN 10ML SYRINGE WAS INVOLVED WITH THE RECEIPT OF AN EXPIRED PRODUCT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306513 LOT# 806871 THE PRODUCT WAS SENT WITH AN EXPIRATION DATE ON THE BOX AND ALL OF THE SYRINGES. THE PRODUCT WAS IN DATE WHEN RECEIVED. WE USE MINIMAL OF THE PRODUCT AND WHEN THE RN USED THE PRODUCT TO FLUSH THE PORT THE PRODUCT WAS EXPIRED. ON THE (B)(6) MARCH I USED 10CC ONE SYRINGE OF HEPARIN SOLUTION TO FLUSH A PORT. THE HEPARIN HAD EXPIRED ON THE (B)(6) MARCH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10035305 ↗MalfunctionJun 4, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF HEPARIN 100UL 5ML FILL IN 10ML SYRINGE EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306513, BATCH NO: UNKNOWN. EVENT DESCRIPTION PER STATES, CUSTOMER SERVICE REP TRANSFERRED CALLER STATING SHE IS HAVING ISSUES WITH SYRINGES AND THE NUMBER LISTED ON THEM. SHE STATED THE NUMBER SHOULD HAVE A DIFFERENT 4 DIGIT CODE IN THE MIDDLE OF EACH (EXAMPLE NDC NUMBER (B)(4) CUSTOMER REP THAT TRANSFERRED CALLER PROVIDED ITEM NUMBERS 306513- 306545 STATING THE ITEM NUMBER IS THE 4 DIGIT CODE PLUS THE LAST TWO DIGITS. ) BECAUSE THAT DETERMINES THE DRUG IN EACH SYRINGE. IT IS CAUSING CONFUSION WHEN SCANNING THE ITEMS. SHE PROVIDED LOT NUMBER-3134965 SODIUM CHLORIDE 10ML FLUSH LOT NUMBER 3135338- HEPARIN 5ML AND 10ML FLUSH SYRINGES, SHE WAS NOT AWARE OF THE PART NUMBERS. CUSTOMER REP THAT TRANSFERRED CALLER PROVIDED ITEM NUMBER. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER STATES, AS PHARMACISTS, WE HAVE ISSUES WITH THE FIRST TWO SEGMENTS OF AN NDC CONTAINING THE SAME INFORMATION FOR TOTALLY DIFFERENT PRODUCTS. HEPARIN IS A HIGH RISK MEDICATION, AND IT IS DISCONCERTING THAT DIFFEREN
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8668812 ↗MalfunctionFeb 21, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BROWN PARTICLES WERE FOUND FLOATING IN THE HEPARIN 100UL 5ML FILL IN 10ML SYRINGE PRIOR TO THE INJECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8359085 ↗MalfunctionAug 3, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER USING THE BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, THE CONSUMER EXPERIENCED SEVERE PAIN IN THEIR BOWELS AND LOWER BACK. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Patient problems: Pain
MAUDE report 7749625 ↗DeathJul 18, 2018Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A PATIENT USED A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 USP UNITS/ML, SHE HAD SYMPTOMS OF DIARRHEA, CONSTIPATION AND NAUSEA. THE PATIENT WAS EVALUATED BY A DOCTOR, DIAGNOSED WITH A BLOOD INFECTION, AND GIVEN ANTIBIOTICS. THE PATIENT ALSO HAD BACTERIA IN HER URINE. THE PATIENT ULTIMATELY PASSED AWAY. 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 RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING
Patient problems: Bacterial Infection; Constipation; Death; Diarrhea; Nausea
MAUDE report 7698490 ↗DeathJul 17, 2018Nonstandard Device; Microbial Contamination of Device
IT WAS REPORTED THAT BETWEEN (B)(6) AND (B)(6) OF 2018, A PATIENT RECEIVED MULTIPLE HEPARIN FLUSHES WITH A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML. IN EARLY (B)(6), THE PATIENT PASSED AWAY. THERE WAS NO REPORT OF INFECTION OR ADDITIONAL INFORMATION REGARDING THIS PATIENT'S DEATH. 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 RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIG
Patient problems: Bacterial Infection; Death
MAUDE report 7696884 ↗DeathJul 17, 2018Nonstandard Device
IT WAS REPORTED THAT A (B)(6) PATIENT WITH A TUNNELED LINE WHO HAD BEEN DIAGNOSED WITH HEART FAILURE, TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018 AND PASSED AWAY. THE PATIENT'S DISCHARGE SUMMARY STATES THAT PATIENT'S MAJOR MEDICAL ILLNESS WAS NON ISCHEMIC CARDIOMYOPATHY, MIXED SEPTIC & CARDIOGENIC SHOCK, HYPOXEMIC RESPIRATORY FAILURE, AND V-TACH ARREST. A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 USP UNITS/ML WAS ASSOCIATED 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 PATIEN
Patient problems: Unspecified Infection
MAUDE report 7696309 ↗InjuryJun 26, 2018Nonstandard Device; Microbial Contamination of Device
IT WAS REPORTED THAT A PATIENT FELT ILL AFTER USING A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML. THE PATIENT INDICATED THAT SHE WOULD CONTACT HER DOCTOR AND GET A BLOOD TEST. 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 RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.
Patient problems: Complaint, Ill-Defined
MAUDE report 7639898 ↗InjuryJun 26, 2018Microbial Contamination of Device
IT WAS REPORTED THAT A PATIENT HAD SYMPTOMS OF BEING UNABLE TO WALK, EXHAUSTION, AND DIZZINESS STARTING ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS TAKEN TO AN EMERGENCY DEPARTMENT FOR EVALUATION AND WAS TOLD HE MAY HAVE A CORONAVIRUS. THE USE OF A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML WAS ASSOCIATED 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 RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT
Patient problems: Bacterial Infection; Dizziness
MAUDE report 7639811 ↗InjuryJun 12, 2018Nonstandard Device; Microbial Contamination of Device
IT WAS REPORTED THAT A (B)(6) FEMALE WITH A DIAGNOSIS OF HODGKIN¿S LYMPHOMA AND A PICC LINE IN PLACE HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) 2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML. 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 (B)(6) ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH
Patient problems: Bacterial Infection
MAUDE report 7594809 ↗InjuryMay 29, 2018Nonstandard Device; Microbial Contamination of Device
IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION AND HAD FEVER, FATIGUE, PALLOR, PAIN AND WEAKNESS WHILE USING A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML AT HOME ON HER PICC LINE. TWO INITIAL SETS OF CULTURES WERE TAKEN AND ON (B)(6) 2018 WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE SOURCE WAS REPORTED TO BE THE PATIENT'S PICC LINE BUT IT WAS NOT CHANGED. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH IV VANCOMYCIN FOR SEVEN DAYS. THE PATIENT WAS DISCHARGED TO HOME AND RECEIVED IV DAPTOMYCIN FOR AN ADDITIONAL 10 DAYS. AS OF (B)(6) 2018, THE PATIENT INDICATED THAT SHE WAS STILL USING IV VANCOMYCIN AND HEPARIN LOCKS THROUGH HER PICC LINE AND ANTICIPATED USING THEM FOR AT LEAST ANOTHER WEEK. 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 (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BA
Patient problems: Bacterial Infection; Fatigue; Fever; Pain; Weakness
MAUDE report 7550772 ↗InjuryMay 24, 2018Nonstandard Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE CDC CONFIRMED A CASE OF SERRATIA MARCESCENS BLOODSTREAM INFECTION FROM (B)(6) WITH PFGE PATTERNS INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE PATIENT IS A (B)(6) MALE DIAGNOSED WITH LYMPHOMA AND IS IMMUNOCOMPROMISED WITH AN IMPLANTED PORT THAT WAS ACCESSED IN AN OUTPATIENT INFUSION CLINIC. THE PATIENT PRESENTED TO A HOSPITAL WITH POSITIVE SERRATIA MARCESCENS CULTURE ON (B)(6) 2018, WAS TREATED, AND SUBSEQUENTLY DISCHARGED. THE SPECIFIC TREATMENT PROVIDED IS UNKNOWN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML. *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 CONNECT
Patient problems: Bacterial Infection
MAUDE report 7541297 ↗InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 USP UNITS/ML WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.
Patient problems: Unspecified Infection
MAUDE report 7467626 ↗InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 USP UNITS/ML WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.
Patient problems: Unspecified Infection
MAUDE report 7467625 ↗DeathApr 23, 2018Microbial Contamination of Device
IT WAS REPORTED THAT ON (B)(6) 2018, A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 USP UNITS/ML WAS USED ON A PATIENT'S PORT. ON (B)(6) 2018, THE PATIENT HAD SYMPTOMS THAT WERE NOT INDICATIVE OF INFECTION BUT BLOOD CULTURES WERE DRAWN FROM THE PORT. ONE OF THE 2 BLOOD CULTURES TURNED POSITIVE FOR SERRATIA MARCESCENS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH SEPSIS. THE PATIENT HAD BLOOD CULTURES DRAWN WHEN THEY PRESENTED WITH SEPSIS ON (B)(6) AND THOSE CULTURES WERE POSITIVE FOR SERRATIA MARCESCENS. ON (B)(6) 2018, THE PATIENT DIED. THE CASE IS NOT YET LINKED TO THE CLUSTER OF SERRATIA INFECTIONS THAT ARE BEING INVESTIGATED BY CDC/FDA. THIS IS A NEW CASE IN TN (NOT ONE THE 4 CASES THAT TN HAS REPORTED TO CDC) WITH A SERRATIA BLOODSTREAM INFECTION WITH A PORT AND HAD RECEIVED HEPARIN AMONG OTHER MEDICATIONS. THE PFGE PATTERN FOR THE SERRATIA FROM THIS PATIENT IS NOT THE SAME AS THE 11 CASES UNDER INVESTIGATION WITH CDC/FDA.
Patient problems: Bacterial Infection; Death
MAUDE report 7453058 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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