BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 17546619 · Received August 14, 2023

    Report

    Report Number
    3003152976-2023-00329
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    June 23, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-AUG-2023 . H6: INVESTIGATION SUMMARY ONE SAMPLE AND PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A WHITE DOT (BUBBLE) WAS OBSERVED WITHIN THE WALL OF BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2002273, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MOLDING PARAMETERS WERE ALSO REVIEWED AND VERIFIED ALL TO BE WITHIN THE VALIDATED PROCESS LIMITS. THIS ISSUE CAN OCCUR DUE TO A LACK OF COMPACTION DURING THE MOLDING PROCESS, CAUSING THE MATERIAL NOT TO SPREAD COMPLETELY, CREATING THE BUBBLE AS OBSERVED IN THE SAMPLE PROVIDED. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE BUBBLE LIKELY GENERATED DURING THE MOLDING PROCESS.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK ¿ - 3-PIECE SYRINGES HAD WHITE PARTICLES AT THE TOP TO THE SYRINGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WHITE PARTICLE INSIDE SYRINGE. AT A HOSPITAL PHARMACY THE STAFF DISCOVERED THAT 2 STERILE SINGLE-USE SYRINGES 20 ML HAD AN INTERNAL WHITE PARTICLE (PROBABLY MOLDING DEFECT) AT THE TOP OF THE SYRINGE. ONE SYRINGE CONTAINING MEDICINAL SUBSTANCE WAS DISCARDED. THE SECOND SYRINGE HAD BEEN INSIDE THE LAF BENCH, BUT IT WAS NOT USED, AS IT WAS RECOGNIZED THAT IT ALSO HAD A WHITE PARTICLE INSIDE THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK ¿ - 3-PIECE SYRINGES HAD WHITE PARTICLES AT THE TOP TO THE SYRINGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WHITE PARTICLE INSIDE SYRINGE. AT A HOSPITAL PHARMACY THE STAFF DISCOVERED THAT 2 STERILE SINGLE-USE SYRINGES 20 ML HAD AN INTERNAL WHITE PARTICLE (PROBABLY MOLDING DEFECT) AT THE TOP OF THE SYRINGE. ONE SYRINGE CONTAINING MEDICINAL SUBSTANCE WAS DISCARDED. THE SECOND SYRINGE HAD BEEN INSIDE THE LAF BENCH, BUT IT WAS NOT USED, AS IT WAS RECOGNIZED THAT IT ALSO HAD A WHITE PARTICLE INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50282 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2002273

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown