BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1 ML SYRINGE, LUER SLIP WITH NEEDLE

    MDR report key: 7412370 · Received April 10, 2018

    Report

    Report Number
    8041187-2018-00094
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 18, 2018
    Report Date
    April 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE RETURNED UNIT AND CONFIRMED THE REPORTED OBSERVATION OF LOOSE BLACK FOREIGN MATTER INSIDE SYRINGE BARREL AND ON PLUNGER. THE LOOSE BLACK FM WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TEST. THE FTIR RESULT SHOWS THAT THE SPECTRUM OF THE FM DID NOT OBTAIN A GOOD MATCH FROM THE LIBRARY BUT THE BEST MATCH IS SILICONE AND OTHER UNKNOWN COMPOUNDS. SILICONE IS USED IN THE MANUFACTURING AND WAS SPRAYED INTO THE BARREL TO EASE THE MOVEMENT OF THE PLUNGER BUT IT WAS NOT BLACK IN COLOR. THE FOREIGN MATTER FROM THE PLUNGER DOES NOT MATCH THE FOREIGN MATTER FROM MANUFACTURE. ROOT CAUSE COULD NOT BE ESTABLISHED. THE DHR FOR BATCH # 7142001 WAS REVIEWED AND NO ABNORMALITY WAS FOUND DURING PRODUCTION. A PIECE OF PACKAGING WITH FOREIGN MATTER WAS DETECTED ION OUTGOING BUT IT IS WITHIN THE AQL SPECIFICATIONS. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. 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 FOREIGN MATTER (DESCRIBED AS ¿BLACK POWDER¿) WAS FOUND AFTER OPENING A BD 1 ML SYRINGE, LUER SLIP WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253815 BD 1 ML SYRINGE, LUER SLIP WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 7142001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other