BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10115852 · Received June 3, 2020

    Report

    Report Number
    3003152976-2020-00237
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 11, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTING THE PRODUCT, THE BARREL OF THE SYRINGE IS OBSERVED TO BE DAMAGED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001253, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AREAS WHERE THE PRODUCT MOVES WITHIN THE MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID DAMAGING THE PRODUCT. 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, IT IS LIKELY THE DAMAGE OCCURRED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. A PROJECT, C-526-19, WAS INITIATED TO HELP REDUCE DAMAGE ON OUR PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIQUID IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE, AND A "SLIGHT DEFORMATION" WAS FOUND AT THE NECK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ON (B)(6)2020, AT THE PREPARATION OF THE PHARMACY FOR INTERNAL USE, DURING A LIQUID SAMPLING, THE PERSON IN CHARGE OF THE ACT NOTICED A LEAK OF THE LIQUID SAMPLED IN THE BODY OF THE SYRINGE. A LEAK IN THE PLUNGER WAS SUSPECTED AND A SLIGHT DEFORMATION OF THE PLASTIC AT THE NECK OF THE SYRINGE WAS OBSERVED. THIS IS A REPEATED INCIDENT FOR THIS REFERENCE WHICH HAD NO CONSEQUENCES IN VIEW OF THE LIQUID SAMPLED."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIQUID IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE, AND A "SLIGHT DEFORMATION" WAS FOUND AT THE NECK OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, AT THE PREPARATION OF THE PHARMACY FOR INTERNAL USE, DURING A LIQUID SAMPLING, THE PERSON IN CHARGE OF THE ACT NOTICED A LEAK OF THE LIQUID SAMPLED IN THE BODY OF THE SYRINGE. A LEAK IN THE PLUNGER WAS SUSPECTED AND A SLIGHT DEFORMATION OF THE PLASTIC AT THE NECK OF THE SYRINGE WAS OBSERVED. THIS IS A REPEATED INCIDENT FOR THIS REFERENCE WHICH HAD NO CONSEQUENCES IN VIEW OF THE LIQUID SAMPLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577884 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other