BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 8950825 · Received August 30, 2019

    Report

    Report Number
    3003916417-2019-00430
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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

    INVESTIGATION SUMMARY: NO SAMPLES/PHOTOS OF THE REPORTED INCIDENT WERE RECEIVED FOR ANALYSIS. A BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE VERIFIED WHERE NO RECORDS RELATED TO FAILURE WERE FOUND. THE RETAIN SAMPLES WERE ANALYZED AND IT WAS POSSIBLE TO IDENTIFY A SMALL DEFORMITY IN THE FIRST THREAD OF THE LUER LOCK (NOZZLE OF THE SYRINGE). THIS DEFORMITY WAS CAUSING THE DIFFICULTY TO ATTACH THE EQUIPMENT TO THE SYRINGE. WE EVALUATED THE PRESS AND THE MOLD AND WE FOUND OUT A GAP IN THE MOLD RACK ASSEMBLY (DEVICE USED TO UNLOAD THE NOZZLE FROM THE SYRINGE). THE PROBLEM WAS CORRECTED BY REPLACING THE SCREW WHICH WAS CAUSING THE CLEARANCE IN THE RACK ASSEMBLY. CAPA 944254 WAS OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD DIFFICULTY CONNECTING TO THE "POLIFIX" DURING USE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "SYRINGE WITH DIFFICULTY OF CONNECTING IN THE POLIFIX. OTHER LUER LOCK SYRINGE UNITS WERE TESTED IN ORDER TO CLARIFY IF THE PROBLEM WAS WITH THE POLIFIX. HOWEVER THE DIFFICULTY WAS FOUND WITH THE SYRINGE WHOSE LOT IS IN THIS NOTIFICATION."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD DIFFICULTY CONNECTING TO THE "POLIFIX" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SYRINGE WITH DIFFICULTY OF CONNECTING IN THE POLIFIX. OTHER LUER LOCK SYRINGE UNITS WERE TESTED IN ORDER TO CLARIFY IF THE PROBLEM WAS WITH THE POLIFIX. HOWEVER THE DIFFICULTY WAS FOUND WITH THE SYRINGE WHOSE LOT IS IN THIS NOTIFICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746303 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8289583

    Patients

    Seq Age Sex Outcome Treatment
    1 Other