BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 6979992 · Received October 26, 2017

    Report

    Report Number
    1911916-2017-00272
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 11, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED IN THE (B)(6) PLANT FOR EVALUATION. IT HAS THE TIP CAP, PLUNGER ROD-STOPPER AND SALINE. THE BARREL LABEL CONFIRMS THE LOT# 7080796. THE SAMPLE SHOWS EMBEDDED FOREIGN MATTER IN THE BARREL WALL, THERE IS FOREIGN MATTER AT THE 2ML MARK AND AT THE LUER TIP. UNDER THE MICROSCOPE WE CAN IDENTIFY THE FOREIGN MATTER AS BRITTLE MATERIAL. FROM PREVIOUS ANALYSIS THIS FOREIGN MATTER CAN BE IDENTIFIED AS: CHLORINATED POLYETHYLENE AND KAOLIN, CHLORINATED POLYETHYLENE- DESCRIBED AS A SOFT, RUBBERY MATERIAL USED IN BLENDS WITH PVC, KAOLIN- MINERAL USED FOR MODIFYING THE PROPERTIES OF RUBBER UPON VULCANIZATION, AMONG OTHER USES. ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WERE NO ISSUES DOCUMENTED ABOUT ANY TYPE OF FOREIGN MATTER. INVESTIGATION CONCLUSION: THIS IS THE FIRST COMPLAINT TO THE BATCH 7080796 FOR THE SAME DEFECT OR SYMPTOM. THERE WERE NO DOCUMENTED ISSUES DURING THE PRODUCTION RUN FOR BATCH 7080796. ORIGIN OF THE FM REMAINS UNKNOWN. PRODUCT WITHIN SPECIFICATION? YES? NO? ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WERE NO ISSUES DOCUMENTED ABOUT ANY TYPE OF FOREIGN MATTER. FROM PREVIOUS ANALYSIS THIS FM CAN BE IDENTIFIED AS: CHLORINATED POLYETHYLENE AND KAOLIN. FROM ONLINE: CHLORINATED POLYETHYLENE- DESCRIBED AS A SOFT, RUBBERY MATERIAL USED IN BLENDS WITH PVC. KAOLIN- MINERAL USED FOR MODIFYING THE PROPERTIES OF RUBBER UPON VULCANIZATION, AMONG OTHER USES. ORIGIN OF THE FM REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: SHOULD BE 09/27/2017- CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH" PRE-FILLED SALINE SYRINGE HAD FOREIGN MATTER INSIDE THE SYRINGE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761694 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7080796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other