BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14226169 · Received April 27, 2022

    Report

    Report Number
    3003152976-2022-00172
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    February 15, 2022
    Report Date
    May 13, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 04-MAY-2022. H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THUMB PRESS WAS OBSERVED TO BE BROKEN. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2112019. THE AREAS WHERE PIECES MOVE WITHIN THE MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE 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 WAS DETERMINED THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGERS BROKE DURING THE LEAKAGE CHECK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "AFTER OPENING A 50 ML BD PLASTIPAK SYRINGE, THE PLUNGER BUTTON ON THE SYRINGE BREAKS DURING THE LEAKAGE CHECK, RESULTING IN A RISK OF INJURY TO THE CAREGIVER. THE SYRINGE IS NOT CONTAMINATED WITH LIQUID. A SYRINGE FROM THE SAME BATCH IS USED WITHOUT PROBLEMS. LOT 2112019, REF. (B)(4)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGERS BROKE DURING THE LEAKAGE CHECK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "AFTER OPENING A 50 ML BD PLASTIPAK SYRINGE, THE PLUNGER BUTTON ON THE SYRINGE BREAKS DURING THE LEAKAGE CHECK, RESULTING IN A RISK OF INJURY TO THE CAREGIVER. THE SYRINGE IS NOT CONTAMINATED WITH LIQUID. A SYRINGE FROM THE SAME BATCH IS USED WITHOUT PROBLEMS. LOT 2112019, REF. 300865."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936574 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown