BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML 21G 1-1/4IN

    MDR report key: 8675539 · Received June 6, 2019

    Report

    Report Number
    2243072-2019-01124
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 8, 2019
    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 SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1812192. FROM VISUAL INSPECTION OF THE RETURNED SAMPLE, SBDM FOUND NEEDLE WITHOUT CAP. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLE FROM LOT 1812182, 1812192, 1901022, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1812192, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD, THERE WERE SIMILAR ISSUE FROM OTHER CUSTOMER. INCOMING INSPECTION RECORD REVIEW OF BULK NEEDLE: SBDM REVIEWED THE INCOMING INSPECTION RECORD FOR BULK NEEDLE LOT.8302568), IT WAS NOTICED THERE WERE NEEDLE CAPS WHICH WERE SEPARATE FROM NEEDLE HUBS IN A NEEDLE BULK PACKAGE. SBDM CONDUCTED TENSILE EXTENSION TEST AND FOUND 1 SAMPLE WAS NOT IN SPEC (136 ~ 1,589GF). TENSILE STRENGTH TEST OF NEEDLES FROM SYRINGE ASSEMBLY LINE: SBDM TESTED 400 PCS OF NEEDLES FROM ASSEMBLY LINE AND CONCLUDED THE MINIMUM TENSILE STRENGTH BETWEEN NEEDLE CAP AND HUB WAS LOW, WITH 1 SAMPLE OUT OF SPEC (82GF). ROOT CAUSE: FROM INVESTIGATIONS, SBDM CONCLUDED THAT NEEDLE WITHOUT CAP IN THE COMPLAINT SAMPLE OCCURRED IN THE ASSEMBLED SYRINGE SUPPLY LINE. THIS IS BECAUSE THE CONSIGNED NEEDLE AND CAP WHICH WERE NOT ASSEMBLED PROPERLY OR LOOSELY WHEN DELIVERED, OR MIGHT HAVE DISASSEMBLED WHILE SUPPLYING ASSEMBLED SYRINGE TO PACKING LINE DUE TO VIBRATION OF SUPPLYING MACHINE. SUBSEQUENTLY THE PACKING PROCESS INSPECTOR MISSED THE NEEDLE WITHOUT CAP, AND IT CAUSED THE COMPLAINT CASE. CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM IMPLEMENTED TIGHTENED PRODUCT & PROCESS INSPECTION AND STRENGTHENING QUALITY INSPECTION FOR SYRINGE MANUFACTURING PROCESS. 3. SBDM IMPLEMENTED 100% VISUAL INSPECTION IN SYRINGE ASSEMBLY & PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 10ML 21G 1-1/4IN EXPERIENCED A MISSING TIP CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO NEEDLE CAP IN THE SYRINGE PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML 21G 1-1/4IN EXPERIENCED A MISSING TIP CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO NEEDLE CAP IN THE SYRINGE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466930 SYRINGE 10ML 21G 1-1/4IN SYRINGE FMF BECTON DICKINSON 1812192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other