5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

Report

Report Number: 2134319-2018-00099
Event Type: Death
Date Received: July 12, 2018
Date of Event: April 12, 2018
Report Date: August 15, 2018
Manufacturer: BECTON DICKINSON MEDICAL SYSTEMS
Product Code: FOZ
PMA / PMN Number: K011967
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: ON 7/12/2018, THE USER FACILITY PROVIDED A CATALOG NUMBER FOR THIS INCIDENT. THE UPDATED INFORMATION IS AS FOLLOWS: MEDICAL DEVICE BRAND NAME: 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML. MEDICAL DEVICE CATALOG #: 306510. UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA / 510(K)#: K011967.

Additional Manufacturer Narrative · 1

DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: DEATH. DEVICE SINGLE USE? NO. DEVICE RETURNED TO MANUFACTURER: NO. INVESTIGATION SUMMARY: AS BOTH A LOT NUMBER AND SAMPLE WERE UNAVAILABLE FOR THIS INCIDENT, A FULL INVESTIGATION CONSISTING OF A SAMPLE ANALYSIS AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. PRIOR TO (B)(6) 2018, THERE WAS NO TREND FOR INFECTION REGARDING THE BD FRANKLIN PRODUCTS. UPON THE INCREASE OF INFECTION REPORTS BEGINNING IN (B)(6) 2018, A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS INITIATED TO ADDRESS THE ISSUE. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 AND JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF LIFE OF THIS PRODUCT. A DIRECT CAUSATION BETWEEN THE REPORTED INFECTION AND DEATH AND THE BD FRANKLIN PRODUCT HAS NOT BEEN IDENTIFIED.

Additional Manufacturer Narrative · 1

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) YEAR OLD 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 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿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, (B)(4).

Description of Event or Problem · 1

"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. AN UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE 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 TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC."

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) YEAR OLD 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. AN UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(4) 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, (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
526249	5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML	PREFILLED HEPARIN FLUSH SYRINGE	FOZ	BECTON DICKINSON MEDICAL SYSTEMS		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR		Death