BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML 21G 1-1/4IN

    MDR report key: 9759152 · Received February 26, 2020

    Report

    Report Number
    2243072-2020-00289
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 19, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1912122. FROM VISUAL INSPECTION, THERE WAS A BLACK SPOT ON THE NEEDLE HUB. INFRARED SPECTROMETRY (IR) ANALYSIS: FROM IR RESULTS, THE FM IS SIMILAR MATERIAL AS NEEDLE HUB (PP). HOUSE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOTS 1912022, 1912122 AND 1912172, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURED RECORD, NO ABNORMALITY OBSERVED. INCOMING INSPECTION RECORD REVIEW OF BULK NEEDLE: SBDM REVIEW THE INCOMING INSPECTION RECORD OF BULK NEEDLE FOR LOT 9155640, NO ABNORMALITY OBSERVED. ROOT CAUSE: FROM IR ANALYSIS, SBDM DETERMINE THAT THE FM IS SAME MATERIAL WITH NEEDLE HUB. CURRENTLY, SBDM CONDUCT 100% VISUAL INSPECTION IN ASSEMBLY AND PACKING ON THE ASSEMBLY PROCESS. THE LIKELY CAUSE IS THAT THE INSPECTORS COULD NOT FIND THE FM ON NEEDLE HUB AND IT CAUSED THE COMPLAINT CASE. THE FM ON NEEDLE HUB WAS LIKELY OCCURRED IN THE NEEDLE HUB INJECTION PROCESS BY THE NEEDLE SUPPLIER. AS THE COMPLAINT NEEDLE WAS SUPPLIED INTO 10ML SYRINGE ASSEMBLY PROCESS, AT THIS TIME THE NEEDLE IS COVERED BY OPAQUE COLOR NEEDLE COVER, BUT THE COLOR OF COVER IS NOT AFFECTED TO INSPECT THE FM. HOWEVER, IF THE NEEDLE IS SUPPLIED INTO THE PACKING LINE BY ONSIDE OF FM THAT THE FM COULD BE DETECTED BY INSPECTOR. ON THE OTHER HAND, IF THE NEEDLE IS SUPPLIED BY OPPOSITE SIDE OF FM THAT THE FM COULD NOT BE FOUND BY INSPECTOR, IT IS IMPOSSIBLE TO FIND THE FM. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM TIGHTEN INCOMING INSPECTION FOR BULK NEEDLES AND KEEP MONITORING OF SYRINGE MANUFACTURING PROCESS TO PREVENT RECURRENCE OF THE SAME CASE. 3. SBDM IMPLEMENTED 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND ALSO HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML 21G 1-1/4IN HAD FOREIGN MATTER ON THE NEEDLE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON THE NEEDLE HUB. BLACK SPOT ON THE NEEDLE HUB.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML 21G 1-1/4IN HAD FOREIGN MATTER ON THE NEEDLE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON THE NEEDLE HUB. BLACK SPOT ON THE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223398 SYRINGE 10ML 21G 1-1/4IN SYRINGE FMF BECTON DICKINSON 1912122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other