BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE AND NEEDLE

    MDR report key: 8516524 · Received April 15, 2019

    Report

    Report Number
    2243072-2019-00731
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 28, 2019
    Report Date
    May 1, 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: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1812182. VISUAL INSPECTION OF RETURNED SAMPLE: SBDM FOUND NEEDLE WITHOUT CAP IN THE RETURNED SAMPLE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 10 PCS EACH FROM LOTS 1812172, 1812182 AND 1812192, NO DEFECTIVE PRODUCTS WAS FOUND. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1812182, NO ABNORMALITY OBSERVED. THERE WAS NO ISSUE AS PER INCOMING INSPECTION OF JOINT FORCE BETWEEN NEEDLE & COVER (FUNCTIONAL INSPECTION) AND NEEDLE ASSEMBLY (VISUAL INSPECTION) FOR THE BULK NEEDLE. ROOT CAUSE: FROM INVESTIGATION, THE LIKELY CAUSE FOR NEEDLE WITHOUT CAP IN THE COMPLAINT SAMPLE OCCURRED IN THE ASSEMBLED SYRINGE SUPPLY LINE. THIS IS BECAUSE NEEDLE AND CAP WERE DISASSEMBLED WHILE SUPPLYING ASSEMBLED SYRINGE TO PACKING LINE DUE TO VIBRATION OF SUPPLYING MACHINE. THE PACKING PROCESS INSPECTOR MISSED THE NEEDLE WITHOUT CAP, AND IT CAUSED THE COMPLAINT CASE. SBDM HAS IN HOUSE CAPA-19-026 IN PLACE TO MONITOR DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE AND NEEDLE WAS MISSING THE CAP. THIS OCCURRED ON 7 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO CAP NEEDLE IN 10ML SYRINGE. UPDATED INFO: COULD YOU PLEASE EXPLAIN HOW CUSTOMER NOTICED SYRINGE PRODUCT COMES WITH MISSING CAP? THE CUSTOMER OBSERVED THE SYRINGE WITH MISSING CAP BEFORE USE. (VISUALLY CHECK). IS THE SYRINGE PACKAGED INDIVIDUAL/ISOLATED FROM OTHERS? NO. THE SYRINGE PACKED WITH OTHERS. ONLY 1 SYRINGE DOESN¿T HAVE THE NEEDLE CAP. WAS CUSTOMER EXPOSED TO THE NEEDLE? IF YES, IS THE NEEDLE IN CONTACT WITH END USER? NO. THE CUSTOMER FOUND IT BEFORE OPENING THE PACKAGE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). (B)(6). DEVICE EVALUATED BY MFR: 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 WAS REPORTED THAT BD¿ SYRINGE AND NEEDLE WAS MISSING THE CAP. THIS OCCURRED ON 7 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO CAP NEEDLE IN 10ML SYRINGE. UPDATED INFO: COULD YOU PLEASE EXPLAIN HOW CUSTOMER NOTICED SYRINGE PRODUCT COMES WITH MISSING CAP? THE CUSTOMER OBSERVED THE SYRINGE WITH MISSING CAP BEFORE USE (VISUALLY CHECKED). IS THE SYRINGE PACKAGED INDIVIDUAL / ISOLATED FROM OTHERS? NO. THE SYRINGE PACKED WITH OTHERS. ONLY 1 SYRINGE DOESN¿T HAVE THE NEEDLE CAP. WAS CUSTOMER EXPOSED TO THE NEEDLE? IF YES, IS THE NEEDLE IN CONTACT WITH END USER? NO. THE CUSTOMER FOUND IT BEFORE OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309185 BD SYRINGE AND NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON 1812182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other