BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 ML BD POSIFLUSH¿ SP SYRINGE

    MDR report key: 7004286 · Received November 6, 2017

    Report

    Report Number
    1911916-2017-00288
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K003553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: WE HAVE BEEN PROVIDED WITH AN OPENED SHELF CARTON, WITH 32 UNITS OF POSIFLUSH¿ SP UNOPENED. SINCE THE DESCRIBED CIRCUMSTANCES HAVE BEEN OBSERVED DURING USE, THIS CAN NOT BE REPLICATED WITH SAMPLE EVALUATION. COMPLAINT TRENDING REVIEW OF THIS LOT AND PRODUCT FAMILY FOR THIS ISSUE REVEALS NO OTHER COMPLAINTS. A BHR FOR THE REPORTED BATCH WAS CONDUCTED CONFIRMING THIS WAS RELEASED ACCORDING TO DEFINED SPECIFICATIONS AND REQUIREMENTS INCLUDING STERILIZATION AND FINAL LAB TESTING: THERE WERE NO QN'S OR ISSUES ASSOCIATED WITH BATCH # 7081385. THERE IS NO DOCUMENTATION FOR ANY ISSUE AFFECTING THE SALINE SOLUTION. ALL INSPECTIONS PERFORMED FROM FILLING TO CASE PACK WERE ACCEPTABLE. CONTROLS IN PLACE AT MANUFACTURING SIDE HAVE BEEN REVIEWED AND FOUND ACCEPTABLE INCLUDING: - BIOBURDEN TESTED DURING WEEK DAYS (MONDAY TO FRIDAY). - OVERKILL STERILIZATION PROCESS'S. THE STERILIZATION PROCESS IS CHALLENGED AND RE-QUALIFIED ANNUALLY. - ENVIRONMENTAL TESTING WITHIN THE FILLING AREA ON A WEEKLY BASIS. - THE SOLUTION IS FILTERED TWICE BEFORE IT IS FILLED IN SYRINGES (NOTE: ONCE WHEN TRANSFERRING TO THE HOLD TANK AND AGAIN AT THE FILL MACHINE). - ENDOTOXIN TESTING IS PERFORMED PER CYCLE. - BIOBURDEN TESTING ON THE COMPONENTS USED TO ASSEMBLE THE SYRINGES, PERFORMED DURING WEEK DAYS (MONDAY TO FRIDAY). - CONTINOUS ONLINE MONITORING OF THE WFI WATER QUALITY (NOTE: THIS IS FOR TOC AND CONDUCTIVITY, NOT MICROBIAL REQUIREMENTS). - BIOBURDEN AND ENDOTOXIN TESTING OF THE USP PURIFIED WATER AND WFI SYSTEMS, PERFORMED DURING WEEK DAYS. - WEEKLY ENDOTOXIN TESTING OF THE PURE STEAM SYSTEM. PART LOTS HAVE ALSO BEEN REVIEWED: - BARREL # 7075419; PLUNGER ROD #7075422, #7013231 AND #6356213; TIP CAP # 7075397, #7069265 AND #7061097: NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. - STOPPER # 7075403: NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. - SALINE SOLUTION # 7075424 AND 7075423: NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE RETURNED SAMPLES DO NOT PRESENT ANY SPECIAL CHARACTERISTIC THAT COULD CAUSE ALLERGIC REACTION. WE CANNOT CONFIRM THE REPORTED ISSUE. AFTER BHR AND MANUFACTURING RECORDS REVIEW, THERE WERE NO ISSUES DOCUMENTED RELATED TO THE REPORTED COMPLAINT. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF BATCH 7081385 AND ALL INSPECTIONS WERE PERFORMED WITH CORRECT RESULTS. THEREFORE, IT HAS NOT BEEN FOUND ANY SPECIFIC CIRCUMSTANCES, FROM MANUFACTURING PROCESS, THAT COULD EXPLAIN THE DESCRIBED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A 10 ML BD POSIFLUSH¿ SP SYRINGE, THE PATIENT EXPERIENCED ANAPHYLAXIS AND WAS ADMITTED TO THE ICU FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781970 10 ML BD POSIFLUSH¿ SP SYRINGE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7081385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention