BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 8659812 · Received May 31, 2019

    Report

    Report Number
    3003916417-2019-00260
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463003782
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE VERIFIED WHERE NO RECORDS RELATED TO FAILURE WERE FOUND. THE SAMPLE PROVIDED WAS EVALUATED AND IT WAS POSSIBLE TO OBSERVE THE INCIDENT. WHEN THE RETENTION SAMPLES WERE EVALUATED, IT WAS POSSIBLE TO VERIFY THE NON-CONFORMITY. WE EVALUATED THE PRESS AND THE MOLD AND WE FOUND OUT A GAP IN THE MOLD RACK ASSEMBLY (DEVICE USED TO EXTRACT THE NOZZLE FROM THE SYRINGE). THE PROBLEM WAS CORRECTED BY REPLACING THE SCREW WHICH WAS CAUSING THE CLEARANCE IN THE RACK ASSEMBLY. (B)(4) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLASTIC BURRS OCCURRED WITH A SYRINGE PLASTIPAK 20ML LL S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS RECEIVED A COMPLAINT REGARDING THE PRODUCT SYRINGE 20ML LUER LOCK (CAT. 990687). "THE LUER LOCK TIP IS WITH PLASTIC BURRS, IT TURNS DIFFICULT TO ATTACH THE SYRINGE TO NEEDLES AND OTHER DEVICES."

    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 PLASTIC BURRS OCCURRED WITH A SYRINGE PLASTIPAK 20ML LL S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS RECEIVED A COMPLAINT REGARDING THE PRODUCT SYRINGE 20ML LUER LOCK (CAT. 990687). "THE LUER LOCK TIP IS WITH PLASTIC BURRS, IT TURNS DIFFICULT TO ATTACH THE SYRINGE TO NEEDLES AND OTHER DEVICES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454434 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9016814 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other