BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 21X1-1/2 RB TW

    MDR report key: 11096903 · Received December 30, 2020

    Report

    Report Number
    1213809-2020-00931
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 6, 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

    H6: INVESTIGATION SUMMARY: TWO PHOTOS AND THREE FULLY SEALED SAFETYGLIDE BLISTER PACKS FROM BATCH 0023085 (P/N 305917) WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE PACKAGING PRINT SLIGHTLY OVERLAPPING THE COLOR STRIPE ON THE PACKAGING. THE PRINT WAS STILL LEGIBLE AND ACCEPTABLE PER PRODUCT SPECIFICATION. THE PHYSICAL SAMPLES APPEARED TO MATCH THE PRODUCT IN DISPLAYED IN ONE OF THE PHOTOS. IT WAS OBSERVED THERE WAS LARGE INK STAINS ON THE PACKAGES LARGE ENOUGH IN SIZE TO BE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. IT WAS LIKELY DUE TO INSUFFICIENT CLEANING OF THE PRINTER AFTER AN ADJUSTMENT. POTENTIAL ROOT CAUSE FOR THE OVERLAPPED PRINT ON THE PACKAGE IS ASSOCIATED WITH THE SUPPLIER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 21X1-1/2 RB TW PACKAGE WAS DAMAGED ON 15 OCCASIONS AND THERE WERE 49 OCCURRENCES OF FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RESOURCES RECEIVED FEEDBACK FROM PHARMACEUTICAL CO., LTD. WHEN OPENING THE PACKAGING OF 10 21G*1 1/2 IN TW SAFETYGLIDE NEEDLE SYRINGES AND FOUND THAT THE NEEDLE WAS DEFECTIVE DURING THE PACKAGING PROCESS. NEEDLE DEFECTS WERE FOUND DURING PACKAGING. THERE ARE 27 INK STAINS ON THE INFORMATION SURFACE OF THE NEEDLE, 14 MISPLACED PRINTING, 1 NEEDLE PACKAGING BAG DAMAGED, 5 REMOVABLE FOREIGN OBJECTS IN THE BAG, 9 IMMOVABLE FOREIGN OBJECTS IN THE BAG, AND 8 FOREIGN OBJECTS OUTSIDE THE BAG. THERE ARE A TOTAL OF 64 DEFECTIVE NEEDLES, WITH A DEFECT RATIO OF 0.68%. NEEDLE INK STAINS AND PRINTING MISALIGNMENT DEFECTS ARE ELIMINATED IN TIME AFTER THE FIRST OCCURRENCE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 21X1-1/2 RB TW PACKAGE WAS DAMAGED ON 15 OCCASIONS AND THERE WERE 49 OCCURRENCES OF FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RESOURCES RECEIVED FEEDBACK FROM PHARMACEUTICAL CO., LTD. WHEN OPENING THE PACKAGING OF 10 21G*1 1/2 IN TW SAFETYGLIDE NEEDLE SYRINGES AND FOUND THAT THE NEEDLE WAS DEFECTIVE DURING THE PACKAGING PROCESS. NEEDLE DEFECTS WERE FOUND DURING PACKAGING. THERE ARE 27 INK STAINS ON THE INFORMATION SURFACE OF THE NEEDLE, 14 MISPLACED PRINTING, 1 NEEDLE PACKAGING BAG DAMAGED, 5 REMOVABLE FOREIGN OBJECTS IN THE BAG, 9 IMMOVABLE FOREIGN OBJECTS IN THE BAG, AND 8 FOREIGN OBJECTS OUTSIDE THE BAG. THERE ARE A TOTAL OF 64 DEFECTIVE NEEDLES, WITH A DEFECT RATIO OF 0.68%. NEEDLE INK STAINS AND PRINTING MISALIGNMENT DEFECTS ARE ELIMINATED IN TIME AFTER THE FIRST OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562817 NEEDLE SFTYGLD 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305917 0023085 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1