BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE

    MDR report key: 14135141 · Received April 18, 2022

    Report

    Report Number
    8041187-2022-00196
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 31, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE DEVICE NAMES/TYPES AND 510K NUMBERS REPORTED TO BE INVOLVED. ADDITIONAL INFORMATION BELOW: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K)#: K941562. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-APR-2022. H.6. INVESTIGATION: TWO PHOTOS, THREE SAMPLES IN OPEN PACKAGING, AND ONE SAMPLE IN SEALED PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST PHOTO, A SLIGHT DOWNWARDS DEFORMATION ON THE EDGE OF THE TOPPER FOR TWO 1ML SYRINGE PRODUCTS WERE OBSERVED. FROM THE SECOND PHOTO, THE TEAM OBSERVED BLACK INK COVERING THE WHOLE SURFACE AREA OF THE SYRINGE BARREL UNTIL THE RETAINER RING FROM APPROXIMATELY 0.9ML SCALE MARKING ONWARDS. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. FOR THE SAMPLE IN THE SEALED PACKAGING, BLACK INK WAS OBSERVED COVERING ONE SIDE OF THE SYRINGE BARREL SURFACE APPROXIMATELY 0.9ML SCALE MARKING ONWARDS, NO DISTORTED STOPPER WAS OBSERVED. FOR ONE OF THE THREE SAMPLES IN OPEN PACKAGING, NO DISTORTED STOPPER WAS OBSERVED BUT BLACK INK WAS OBSERVED COVERING THE WHOLE SURFACE AREA OF THE SYRINGE BARREL APPROXIMATELY 0.85ML SCALE MARKING ONWARDS. TWO OF THE THREE SAMPLES IN OPEN PACKAGING WERE OBSERVED WITH THE TOP EDGE OF THE STOPPER DISTORTED DOWNWARDS INSIDE THE SYRINGE BARREL AND NO INK STAIN ON THE BARREL. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE 1 ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE BD CANAAN QUALITY TEAM HAS PERFORMED A SUPPLEMENTAL INVESTIGATION. THE POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE SMEARED PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THERE WAS A QUALITY NOTIFICATION FOR THIS ISSUE RAISED AND THE AFFECTED PRODUCT WAS SCRAPPED. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPERS IN 2 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGES WERE DEFECTIVE/DAMAGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPERS IN 2 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGES WERE DEFECTIVE/DAMAGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819343 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1237349 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown