BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 8489872 · Received April 7, 2019

    Report

    Report Number
    3003916417-2019-00188
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    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: A BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE VERIFIED WHERE NO RECORDS RELATED TO FAILURE WERE FOUND. DESPITE THE FACT THAT NO SAMPLES OR PHOTOS WERE SENT, IT WAS POSSIBLE TO VERIFY THE NON-CONFORMITY THROUGH DEVICE HISTORY REVIEW (DHR). 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 ACCORDING TO MAINTENANCE ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PLASTIPAK 20ML LL S/SU EXPERIENCED DIFFICULTY ATTACHING NEEDLE TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20ML SYRINGE DOES NOT CONNECT WELL TO NEEDLES WITH LARGE CALIBER . INFORMATION RECEIVED BY EMAIL ON 4/3/2019: THE MATERIAL NUMBER IS 990687. THE BATCH NUMBER IS 8316824. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO LEAKAGE OF THE DRUG. THERE WAS NO EXPOSURE OF DRUG OR BLOOD TO THE SKIN. SAMPLE IS AVAILABLE. ANVISA WAS NOT NOTIFIED.

    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 SYRINGE PLASTIPAK 20ML LL S/SU EXPERIENCED DIFFICULTY ATTACHING NEEDLE TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20ML SYRINGE DOES NOT CONNECT WELL TO NEEDLES WITH LARGE CALIBER . INFORMATION RECEIVED BY EMAIL ON 4/3/2019: THE MATERIAL NUMBER IS 990687. THE BATCH NUMBER IS 8316824. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO LEAKAGE OF THE DRUG. THERE WAS NO EXPOSURE OF DRUG OR BLOOD TO THE SKIN. SAMPLE IS AVAILABLE. ANVISA WAS NOT NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283055 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8316824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other