BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE LS TW/ HYPODERMIC

    MDR report key: 7695633 · Received July 17, 2018

    Report

    Report Number
    8041187-2018-00238
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 21, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE (1) SAMPLE WITH SEAL PACKAGING RETURNED FOR INVESTIGATION. OBSERVED BLACK SUBSTANCE WHICH COULD BE GREASE INSIDE THE PACKAGING.A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: THERE WAS A JAMMED AT PICK & PLACE STATION ON (B)(6) 2017, SUSPECTED THE FOREIGN MATTER WITH GREASE DROPPED ON THE SYRINGE DURING PT PERFORMED TROUBLESHOOTING. THE NONCONFORMANCE WAS NOT DETECTED BY THE PT. HENCE, NONCONFORMANCE MATERIAL ESCAPEE AND FLOW TO NEXT PROCESS.

    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: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO.

    Additional Manufacturer Narrative · 0

    CORRECTION: PER ADVERSE EVENTS QUESTIONNAIRE, THIS IS NOT MDR REPORTABLE. FOREIGN MATTER ON THE EXTERNAL SURFACES OF THE DEVICE OR PACKAGE WILL NOT AFFECT THE DEVICE'S ABILITY TO FUNCTION AS INTENDED NOR LEAD TO HARM/SERIOUS INJURY TO A PATIENT OR USER. NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION OR DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE LS TW/ HYPODERMIC HAD AN "ABNORMAL APPEARANCE". THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE LS TW/ HYPODERMIC HAD AN "ABNORMAL APPEARANCE". THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE LS TW/ HYPODERMIC HAD AN "ABNORMAL APPEARANCE". THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE LS TW/ HYPODERMIC HAD AN "ABNORMAL APPEARANCE". THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538114 BD¿ SYRINGE LS TW/ HYPODERMIC HYPODERMIC SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7292028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other