5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
Report
- Report Number
- 2134319-2018-00096
- Event Type
- Injury
- Date Received
- July 12, 2018
- Date of Event
- May 10, 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
INVESTIGATION SUMMARY: PRIOR TO THE REPORT OF INFECTION EVALUATED IN MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. CAPA 350041 WAS INITIATED TO ADDRESS THIS ISSUE DHR: N/A, NO LOT. 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. SAMPLES AND/OR PICTURES WERE NOT PROVIDED. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. INVESTIGATION CONCLUSION: THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA 350041 HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT. CAPA 350041 HAS BEEN INITIATED FOR THIS ISSUE. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.
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.
"IT WAS REPORTED THAT A 69 YEAR OLD PATIENT WITH A PORT WHO HAD BEEN DIAGNOSED WITH CNS LYMPHOMA TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018. 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."
IT WAS REPORTED THAT A 69 YEAR OLD PATIENT WITH A PORT WHO HAD BEEN DIAGNOSED WITH CNS LYMPHOMA TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018. 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 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.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A (B)(6) PATIENT WITH A PORT WHO HAD BEEN DIAGNOSED WITH CNS LYMPHOMA TESTED POSITIVE FOR SERRATIA ON (B)(6) 2018. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526336 | 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 | 69 YR | Other |