BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 7355968 · Received March 20, 2018

    Report

    Report Number
    1911916-2018-00122
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    December 27, 2017
    Report Date
    March 20, 2018
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THIS IS THE FIRST COMPLAINT FOR LOT# 7163564 FOR THE SAME DEFECT OR SYMPTOM. A SAMPLE WAS RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION. IT HAS NO PACKAGING FLOW WRAP. THE BARREL LABEL CONFIRMS THE LOT# 7163564. IT HAS THE PLUNGER ROD- RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL IS BOWED AT THE LUER TIP SECTION. FAILURE MODE IS VERIFIED. THIS TYPE OF DEFECT IS NOT COMMON AND MOST LIKELY WAS INDUCED BY MISPLACEMENT ON THE STERILIZER TRAYS. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL OUR INSPECTIONS AND TESTING PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. INVESTIGATION CONCLUSION: ALL OUR INSPECTIONS AND TESTING PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. A SAMPLE WAS RECEIVED (B)(6) 2018. IT HAS NO PACKAGING FLOW WRAP. THE BARREL LABEL CONFIRMS THE LOT# 7163564. IT HAS THE PLUNGER ROD- RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL IS BOWED AT THE LUER TIP SECTION. PRODUCT WAS NOT WITHIN SPECIFICATIONS. ROOT CAUSE DESCRIPTION: ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS AND TESTING WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. (B)(6) 2018. THE SAMPLE SHOWS THE BARREL BOWED, THIS TYPE OF DEFECT IS NOT COMMON AND MOST LIKELY WAS INDUCED BY MISPLACEMENT ON THE STERILIZER TRAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BARREL WAS DEFORMED CAUSING VOLUME INACCURACY ON A BD 5ML POSIFLUSH¿ SYRINGES PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194872 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7163564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other