BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ WITH NEEDLE

    MDR report key: 7698831 · Received July 18, 2018

    Report

    Report Number
    3002682307-2018-00171
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A BATCH HISTORY REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ALTHOUGH THE DEFECT WAS NOT CONFIRMED FOR THIS INSTANCE, BD HAS RECENTLY INVESTIGATED A SIMILAR COMPLAINT FOR THIS PRODUCT AND FOUND A LEAKAGE MAY OCCUR AS A RESULT OF A DAMAGE IN THE PLUNGER LIP. INVESTIGATION CONCLUSION: NOT ABLE TO DETERMINE. DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    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: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE HAD "SOLUTION LEAKED FROM THE PLUNGER TIP IN BARREL WHEN WITHDRAWN SOLUTION BEFORE USE" THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE HAD "SOLUTION LEAKED FROM THE PLUNGER TIP IN BARREL WHEN WITHDRAWN SOLUTION BEFORE USE" THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE WITH NEEDLE HAD "SOLUTION LEAKED FROM THE PLUNGER TIP IN BARREL WHEN WITHDRAWN SOLUTION BEFORE USE" THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541246 BD SYRINGE¿ WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1702201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other