BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 8765421 · Received July 5, 2019

    Report

    Report Number
    1213809-2019-00704
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 11, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE OPENED EMPTY 10ML CONVENIENCE TRAY WITHOUT TOP WEB IN A PLASTIC ZIP LOCK BAG WAS RECEIVED AND VISUALLY EVALUATED. A SMALL REDDISH PARTICLE WAS OBSERVED LOOSE AT THE BOTTOM OF THE TRAY. THE PARTICLE WAS FIBROUS IN COMPOSITION AND WAS SLIGHTLY LARGER THAN LEVEL 3 IN SIZE, WHICH IS 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 LIKELY ASSOCIATED WITH THE PACKAGING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER CONTAMINATION NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309605 BATCH NO. 9002961, 8285690, AND 8303798 PER EMAIL: 1.RED PARTICULATE WAS FOUND INSIDE A BOX OF SYRINGES, EXACT LOT # UNKNOWN, BUT IT IS BETWEEN LOT 9002961, 8285690, AND 8303798.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9002961, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 8285690, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2018-10-31. MEDICAL DEVICE LOT #: 8303798, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2018-11-29. 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 THREE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER CONTAMINATION NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309605, BATCH NO. 9002961, 8285690, AND 8303798. PER EMAIL: RED PARTICULATE WAS FOUND INSIDE A BOX OF SYRINGES, EXACT LOT # UNKNOWN, BUT IT IS BETWEEN LOT 9002961, 8285690, AND 8303798.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559230 SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other