BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 21X1-1/2 RB TW

    MDR report key: 10998883 · Received December 13, 2020

    Report

    Report Number
    1213809-2020-00890
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND THREE SAFETYGLIDE NEEDLES ASSEMBLIES IN FULLY SEALED BLISTER PACKS FROM BATCH 0023085 (P/N 305917) WERE RECEIVED AND EVALUATED. ONE OF THE PHOTOS DISPLAYED PRODUCT CONSISTENT WITH THE PHYSICAL SAMPLES RECEIVED. ONE PHOTO DISPLAYED THE TOP WEB OF FIVE BLISTER PACKS, EACH WITH A BLACK FOREIGN MATTER PARTICLE ATTACHED. THE COMPOSITION OF THE PARTICLES COULD NOT BE DETERMINED, AND THE DEFECT COULD NOT BE CONFIRMED. ONE NEEDLE ASSEMBLY HAD A PURPLE HUB STUCK INSIDE THE SHIELD, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE HAD AN EMBEDDED FOREIGN MATTER PARTICLE THAT APPEARED TO BE BURNT PLASTIC ATTACHED TO THE SHIELD, WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE HAS SMALL LOOSE BLACK FOREIGN MATTER PARTICLES OUTSIDE THE FLUID PATH ON THE INSIDE OF THE PACKAGE. POTENTIAL ROOT CAUSE FOR THE LOOSE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. POTENTIAL ROOT CAUSE FOR FOREIGN MATTER HUB AND EMBEDDED FOREIGN MATTER DEFECTS ARE ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. POTENTIAL ROOT CAUSE FOR THE BLACK FOREIGN MATTER ATTACHED TO THE TOP WEB COULD NOT BE DETERMINED BASED ON THE PHOTOS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 21X1-1/2 RB TW HAD 6 ABNORMALLY PRINTED NEEDLES AND 26 OCCURRENCE OF FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON NOVEMBER 12, 2020, RESOURCES RECEIVED FEEDBACK FROM PHARMACEUTICAL CO., LTD. WHEN OPENING THE PACKAGING OF 10 21G*1 1/2 IN TW SAFETYGLIDE NEEDLE SYRINGES, IT FOUND THAT NEEDLE DEFECTS WERE FOUND IN THE PRODUCT PACKAGING. THERE ARE 6 ABNORMALLY PRINTED NEEDLES IN THE PACKAGING BAG, 1 NEEDLE WITH PURPLE UNKNOWN FOREIGN MATTER, 7 REMOVABLE FOREIGN OBJECTS IN THE BAG, AND 6 NON-MOVABLE FOREIGN OBJECTS IN THE BAG. THERE ARE 12 BLACK SPOTS ON THE OUTSIDE OF THE BAG. ELIMINATED PROMPTLY AFTER DISCOVERY.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0008471, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-08. MEDICAL DEVICE LOT #: 0023085, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-01-23. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 21X1-1/2 RB TW HAD 6 ABNORMALLY PRINTED NEEDLES AND 26 OCCURRENCE OF FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, RESOURCES RECEIVED FEEDBACK FROM PHARMACEUTICAL CO., LTD. WHEN OPENING THE PACKAGING OF 10 21G*1 1/2 IN TW SAFETYGLIDE NEEDLE SYRINGES, IT FOUND THAT NEEDLE DEFECTS WERE FOUND IN THE PRODUCT PACKAGING. THERE ARE 6 ABNORMALLY PRINTED NEEDLES IN THE PACKAGING BAG, 1 NEEDLE WITH PURPLE UNKNOWN FOREIGN MATTER, 7 REMOVABLE FOREIGN OBJECTS IN THE BAG, AND 6 NON-MOVABLE FOREIGN OBJECTS IN THE BAG. THERE ARE 12 BLACK SPOTS ON THE OUTSIDE OF THE BAG. ELIMINATED PROMPTLY AFTER DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462241 NEEDLE SFTYGLD 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305917 SEE H.10 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1