BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7660561 · Received July 3, 2018

    Report

    Report Number
    1911916-2018-00341
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 17, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K982558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLUNGER ROD OF A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS BROKEN, BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED FOR EVALUATION BY ONE OF OUR QUALITY ENGINEERS. THE SAMPLES HAVE NO PACKAGING FLOW WRAP. THEY ALL HAVE THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABELS CONFIRM THE LOT# 7250637. NONE OF THEM HAVE THE PLUNGER ROD THUMB PRESS DAMAGED, HOWEVER, ALL OF THE SAMPLES HAVE THE BARREL/FLANGE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. IT IS POSSIBLE THAT THE PLUNGER ROD LABELER EQUIPMENT EXPERIENCED A VARIATION. ADJUSTMENTS HAVE BEEN VERIFIED. A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A DEVICE HISTORY REVIEW WAS COMPLETED AND THERE WERE NO DOCUMENTED ISSUES FOR THE COMPLAINT OF BATCH 7250637 DURING THIS PRODUCTION RUN. THERE WERE NO QUALITY NOTIFICATIONS WERE ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WAS NO ISSUE DOCUMENTED ABOUT BARREL/FLANGE DAMAGED. INVESTIGATION CONCLUSION: ALL OUR INSPECTIONS AND TESTING PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. UPDATE JUN 26, 2018. FIVE (5) SAMPLES WERE RECEIVED. SIX (6) HAVE NO PACKAGING FLOW WRAP, THEY ALL HAVE THE PLUNGER ROD-RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABELS CONFIRM THE LOT# 7250637. ALL SEVEN (7) HAVE THE BARREL/FLANGE DAMAGED. NONE OF THEM HAVE THE PLUNGER ROD THUMB PRESS DAMAGED. PRODUCT WITHIN SPECIFICATION? YES / NO. 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. ROOT CAUSE. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLE EXPERIENCED A VARIATION; ANYWAY, ADJUSTMENTS HAVE BEEN VERIFIED. RATIONALE: CAPA (B)(4) HAS BEEN OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLUNGER ROD OF A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS BROKEN, BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500000 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7250637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other