BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12298473 · Received August 9, 2021

    Report

    Report Number
    3003152976-2021-00463
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 13, 2021
    Report Date
    September 13, 2021
    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: 8/17/2021. H.6. INVESTIGATION: PHOTOS AND ONE 50LL SYRINGE WITH REFERENCE 300865 AND LOT NUMBER 2102081RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE RECEIVED IT CAN BE OBSERVED THE STOPPER IS NOT CORRECTLY ASSEMBLED. THE REST OF THE COMPONENTS DO NOT PRESENT ANY DEFECT. WHEN THE STOPPER IS DISASSEMBLED, NO DEFECTS CAN BE SEEN. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 2102081. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, VERIFYING NO DEFECTS ON THE PRODUCT. INSPECTION RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PASSING THE SYRINGE THROUGH THE PERACETIC ACID STERILIZER, PART OF THE PISTON (THE HEAD OF THE PISTON) OF THE SYRINGE MELTED, MAKING THE DM UNUSABLE.

    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 THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PASSING THE SYRINGE THROUGH THE PERACETIC ACID STERILIZER, PART OF THE PISTON (THE HEAD OF THE PISTON) OF THE SYRINGE MELTED, MAKING THE DM UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194845 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2102081

    Patients

    Seq Age Sex Outcome Treatment
    1