BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 5ML LUER-LOK¿ SYRINGE

    MDR report key: 6825950 · Received August 28, 2017

    Report

    Report Number
    1213809-2017-00077
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 11, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) RESULTS: THREE PHOTOS WERE RECEIVED BY BD CANAAN DEPICTING 14 ASSEMBLED 5ML SYRINGES FROM A REPORTED BATCH #7122533 (P/N 309649). VISUAL EVALUATION OF THE PHOTOS REVEALED PRINT DEFECTS, PRIMARILY MISSING PRINT, BETWEEN 4ML AND 5ML GRAD LINES OF REJECTABLE QUALITY. A DEVICE HISTORY REVIEW FOR BATCH 7122533 (P/N 309649) REVEALED THAT THERE WAS A PRINT DEFECT DURING THE MANUFACTURE OF THIS BATCH. CONCLUSION: WE WERE ABLE TO DETERMINE THAT THE ROOT CAUSE FOR THIS INCIDENT WAS DUE TO HARDWARE FAILURE ON THE PRINTING MACHINE. THIS IS AN ISOLATED INCIDENT THAT WAS ADDRESSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THEIR SHIPMENT OF BD PLASTIPAK¿ 5ML LUER-LOK¿ SYRINGES, THERE WERE SEVERAL THAT HAD MISSING OR ILLEGIBLE GRADUATION MARKINGS, MAKING THEM UNUSABLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605736 BD PLASTIPAK¿ 5ML LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7122533

    Patients

    Seq Age Sex Outcome Treatment
    1 Other