BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    MDR report key: 8940408 · Received August 28, 2019

    Report

    Report Number
    3003152976-2019-00588
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 3, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION IT WAS OBSERVED THAT ONE SIDE OF THE BLISTER PACKAGE IS NOT SEALED. IT WAS NOTED WHEN EVALUATING THE PRODUCT THAT THE PACKAGE WAS NOT CUT CORRECTLY. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1905265 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. DURING THE PRIMARY PACKAGING PROCESS, FILM AND PAPER ARE GUIDED ALONG A CHAIN IN THE PACKAGING MACHINE. ONCE THE BLISTER PACKAGING IS SEALED, LONGITUDINAL AND TRANSVERSAL CUTTERS CUT THE EXTRA PIECES OF FILM AND PAPER. A PHOTO-CELL SYSTEM IS USED TO DETECT IF PACKAGING IS MOVED FROM THE PROPER POSITION AND INITIATES AN ALARM TO NOTIFY THE OPERATOR. CONCLUSION: WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS MALFUNCTION OCCURRED DUE TO A DESYNCHRONIZATION OF THE CUTTERS. AS A RESULT, THE PACKAGING WAS CUT IN THE INCORRECT PORTION, RESULTING IN THE OPEN BLISTER PACK THAT WAS REPORTED. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PLAN, WE BELIEVE THIS IS AN ISOLATED INCIDENT WITH AN UNLIKELY REOCCURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE BREACH WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SYRINGE PACKAGING AT ONE END OF PACKET NOT SEALED PROPERLY DURING MANUFACTURING."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE BREACH WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SYRINGE PACKAGING AT ONE END OF PACKET NOT SEALED PROPERLY DURING MANUFACTURING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736043 BD PLASTIPAK 20ML SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. 1905265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other