BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CE

    MDR report key: 9130021 · Received September 27, 2019

    Report

    Report Number
    1911916-2019-01020
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 11, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. INVESTIGATION SUMMARY: THREE SAMPLES AND PHOTOS WERE RECEIVED FOR INVESTIGATION. THEY ALL ARE IN THE SEALED PACKAGING FLOW WRAP, THEY HAVE THE PLUNGER ROD-RUBBER STOPPER, TIP CAP, SALINE SOLUTION AND THE BARREL LABEL. THE BARREL LABEL IDENTIFIES THE PRODUCT AS EWO-2019-135. THE EWO-2019-135 RECORDS WERE REVIEWED. THIS EWO WAS INTENDED TO EVALUATE A DIFFERENT GLUE FOR THE PACKAGING BOXES. THE POSIFLUSH¿ PRODUCT WAS UNDERGOING A PACKAGING CHANGE TO TEST NEW GLUE USED ON THE BOXES OF THE PRODUCT. EVEN THOUGH THE POSIFLUSH¿ PRODUCT INSIDE THE BOX WAS OUR MARKETED PRODUCT INTENDED FOR HUMAN USE AND WAS COMMERCIALLY READY AND SAFE TO USE, OUR PROCESS IS TO LABEL ALL COMPONENTS AS ¿EXPERIMENTAL¿ DURING ANY TYPE OF PACKAGING CHANGE. PER STANDARD PRACTICE, BD ADVISED THE CUSTOMER TO NOT USE ANY POSIFLUSH¿ PRODUCT WITH EXPERIMENTAL LABELING. BD IS NOT AWARE OF ANY OTHER CUSTOMER THAT RECEIVED PRODUCT WITH THE EXPERIMENTAL LABEL. POSIFLUSH¿ IS A PRE-FILLED SYRINGE CONTAINING SALINE FOR USE IN ¿FLUSHING¿ OR CLEARING IV LINES AND CATHETERS. POTENTIAL ROOT CAUSE, THE PACKAGING PROCESS. LINE CLEARANCE NOT ADEQUATE AFTER THE EWO WAS COMPLETED. IMMEDIATE ACTION. NO MORE EWOS ARE TO BE RUN UNTIL WE ASSESS THE CURRENT PROCESS AND CONFIRM WHAT ADDITIONAL ACTIONS CAN BE TAKEN. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML SALINE FILL CE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK AND INCORRECT LABEL INFORMATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306575 BATCH NO: UNKNOWN. PER CUSTOMER EMAIL: WE FOUND SOME OF OUR 10 ML NS SYRINGES IN THE DRAWER OF ONE OF THE SUPPLY ROOMS THAT WERE LABELED AS FOR EXPERIMENTAL USE ONLY- NOT FOR HUMAN USE. THEY ALSO DID NOT SAY NORMAL SALINE ON IT. THEY WERE PACKAGED THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925890 SYRINGE 10ML SALINE FILL CE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other