BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 12206855 · Received July 21, 2021

    Report

    Report Number
    3003152976-2021-00414
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 15, 2021
    Report Date
    August 11, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE SAMPLES WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION IT WAS OBSERVED THAT TOP WEB OF THE PACKAGE HAS A RED TAPE AND TWO PAPER BACKING ARE OVERLAPPED, THE RED TAPE PREVENTING THE PROPER SEALING OF THE BLISTER PACKAGE. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 2102076 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. THIS ADHESIVE TAPE IS USED DURING THE PACKAGING PROCESS WHEN THE PAPER ROLL IS REPLACED, ADHERING THE END OF THE ROLL TO THE NEW ROLL. THERE IS A DETECTOR IN THE PACKAGING MACHINE TO IDENTIFY THIS PORTION OF MATERIAL AND AUTOMATICALLY REJECT TO SCRAP. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO THE REPLACEMENT OF THE PAPER COIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL PACKAGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON JUNE 15, WE ORDERED AND RECEIVED 20 BOXES OF BD SYRINGE BD PLASTIPAK 10 ML 3 PIECE LUER -LOCK -100 PIECES I3 THROUGH THE MEDICAL TRADE (FACTORY SPAIN). THIS ARTICLE NUMBER WE HAVE ALREADY RECEIVED MANY TIMES THROUGH BD. BOXES LOOKED GOOD, NO DAMAGE ETC. WHEN OPENING THE FIRST BOX WE FOUND: DOUBLE LAMINATE, RED TAPE ON SOME LAMINATE PIECES AND SYRINGES NOT QUITE CLOSED SO NOT STERILE. WHEN CHECKING THE OTHER BOXES WERE IN ORDER, CONCLUSION 1 BOX WITH PRODUCTION ERROR.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 10ML LL PACKAGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON JUNE 15, WE ORDERED AND RECEIVED 20 BOXES OF BD SYRINGE BD PLASTIPAK 10 ML 3 PIECE LUER -LOCK -100 PIECES I3 THROUGH THE MEDICAL TRADE (FACTORY SPAIN). THIS ARTICLE NUMBER WE HAVE ALREADY RECEIVED MANY TIMES THROUGH BD. BOXES LOOKED GOOD, NO DAMAGE ETC. WHEN OPENING THE FIRST BOX WE FOUND: DOUBLE LAMINATE, RED TAPE ON SOME LAMINATE PIECES AND SYRINGES NOT QUITE CLOSED SO NOT STERILE. WHEN CHECKING THE OTHER BOXES WERE IN ORDER, CONCLUSION 1 BOX WITH PRODUCTION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099382 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2102076

    Patients

    Seq Age Sex Outcome Treatment
    1