BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 8922378 · Received August 22, 2019

    Report

    Report Number
    1213809-2019-00853
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 7, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAFETYGLIDE NEEDLE ASSEMBLY IN AN OPENED BLISTER PACK FROM BATCH 8110715 (P/N 305916) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A STRAND OF BLACK FOREIGN MATTER WRAPPED AROUND THE HUB AND EXTENDING INTO THE SHIELD. IT APPEARED TO BE HAIR AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8110715 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE NEEDLE SFTYGLD 25X1 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A PIECE OF HAIR WAS FOUND IN THE PRODUCT. PER EMAIL: CALLED TO REPORT A PIECE OF HAIR WAS FOUND IN ITEM # 8110715.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE NEEDLE SFTYGLD 25X1 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A PIECE OF HAIR WAS FOUND IN THE PRODUCT. PER EMAIL: CALLED TO REPORT A PIECE OF HAIR WAS FOUND IN ITEM # 8110715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714405 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8110715 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other