BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 12247145 · Received July 29, 2021

    Report

    Report Number
    9614033-2021-00084
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION, UPON INSPECTION EMPTY PACKAGE AND MISSING LABEL IS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 0253559, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE FOR EMPTY PACKAGE IS ASSOCIATED WITH THE VISION SYSTEM, FOR MISSING LABEL IS ASSOCIATED WITH THE VISION SYSTEM. CORRECTIVE ACTION FOR PACKAGE EMPTY, A NEW LINE CLEARANCE WAS GENERATED TO REVIEW THE BENCH WHEN THERE IS A MINOR OR MAJOR INTERVENTION TO VERIFY THAT THERE ARE NO EMPTY PIECES, THE BATCH REPORTED IN THIS CLAIM WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS ACTIVITY. CORRECTIVE ACTION FOR MISSING LABEL INCLUDE PLACING A VISION SENSOR IN THE LINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE PACKAGING UNITS WERE MISSING THEIR LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "THEY REPORTED TO ME IN THE WAREHOUSE THAT 2 PACKAGES OF SYRINGES CAME OUT WITHOUT THE MATERIAL INSIDE AND IN ANOTHER 2 THE INFORMATION ON THE MATERIAL IN THE ATTACHED PHOTO PACKAGE DID NOT COME."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 2 BD PLASTIPAK¿ SYRINGE PACKAGING UNITS WERE MISSING THEIR LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "THEY REPORTED TO ME IN THE WAREHOUSE THAT 2 PACKAGES OF SYRINGES CAME OUT WITHOUT THE MATERIAL INSIDE AND IN ANOTHER 2 THE INFORMATION ON THE MATERIAL IN THE ATTACHED PHOTO PACKAGE DID NOT COME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146371 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 0253559

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown