BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 15195515 · Received August 9, 2022

    Report

    Report Number
    3003152976-2022-00360
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 13, 2022
    Report Date
    October 25, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A SMALL BLACK PARTICLE WAS OBSERVED INSIDE THE SYRINGE. IT CANNOT BE DETERMINED IF THE PARTICLE IS EMBEDDED WITHIN THE SYRINGE OR LOOSE INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203079, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. MANUFACTURING EQUIPMENT UNDERGOES ROUTINE MAINTENANCE AND CLEANING. 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. WITHOUT THE PHYSICAL SAMPLE TO BETTER EVALUATE THE PARTICLE AND GIVEN THE DEVICE RECORDS DO NOT INDICATE ANY ISSUE RELATED TO THE REPORTED INCIDENT, WE CANNOT IDENTIFY WHERE THE PARTICLE ORIGINATED FROM AT THIS TIME. A PROJECT WAS INITIATED TO REDUCE ANY FOREIGN PARTICLES INSIDE OUR PRODUCTS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 28-SEP-2022. H6: INVESTIGATION SUMMARY SEVERAL PHYSICAL SAMPLES ALONG WITH ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, A SMALL BLACK PARTICLE CONSISTENT WITH BURNT MATERIAL, WAS OBSERVED INSIDE THE SYRINGE. WHEN EVALUATING THE PHYSICAL SAMPLE, NO PARTICLES WERE IDENTIFIED WITHIN ANY OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203079, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE AND GIVEN THE DEVICE RECORDS DO NOT INDICATE ANY ISSUE RELATED TO THE REPORTED INCIDENT, BASED ON THE PHYSICAL APPEARANCE OF THE PARTICLE IN THE PHOTO, IT IS LIKELY IT IS BURNT MATERIAL THAT GENERATED DURING THE MOLDING PROCESS. A PROJECT WAS INITIATED TO REDUCE ANY FOREIGN PARTICLES INSIDE OUR PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE SEEMS TO HAVE A PIECE OF RUBBER IN THE SYRINGE (FOREIGN MATTER). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ALSO HAVE A COUPLE OF SYRINGES WHERE THERE REALLY SEEMS TO BE A PIECE OF RUBBER? IN THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE SEEMS TO HAVE A PIECE OF RUBBER IN THE SYRINGE (FOREIGN MATTER). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ALSO HAVE A COUPLE OF SYRINGES WHERE THERE REALLY SEEMS TO BE A PIECE OF RUBBER? IN THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE SEEMS TO HAVE A PIECE OF RUBBER IN THE SYRINGE (FOREIGN MATTER). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ALSO HAVE A COUPLE OF SYRINGES WHERE THERE REALLY SEEMS TO BE A PIECE OF RUBBER? IN THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989475 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown