BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SER PLASTIPAK 1MLS TUB PDR1400

    MDR report key: 10305947 · Received July 21, 2020

    Report

    Report Number
    3003916417-2020-00211
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 18, 2020
    Report Date
    August 3, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 2020-07-09 H.6. INVESTIGATION SUMMARY SAMPLES AND PHOTO OF REPORTED INCIDENT WERE RECEIVED TO ANALYSIS. IN THE EVALUATION IT WAS POSSIBLE TO OBSERVE THE PRESENCE OF FLASHES IN THE PLUNGER AND ALSO A COLOR VARIATION IN THE AREA WITH THE FLASH. DURING THE DHR AND QNS REVIEW, IT WAS POSSIBLE TO IDENTIFY THAT THE EQUIPMENT PRESENTED FAILURES DURING THE PROCESS AND ALSO THAT IT WAS NOT POSSIBLE TO COMPLETE CONTAIN THE DEFECT IN THE LINE. THE CAUSE IS DIRECTLY CORRELATED TO MECHANICAL AND ELECTRICAL PROBLEMS IN THE MOLDING MACHINE MOIJ-49 AND THE MOLD H-13. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SER PLASTIPAK 1MLS TUB PDR1400 PLUNGER WAS FOUND DEFORMED AND DISCOLORED TO A "REDDISH BROWN" BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN PRODUCING LIQUEMINE WITH THE PLASTIPAK TURBECULIN SYRINGE (REF: 990189), IT WAS NOTICE THE PRESENCE OF ATYPICAL COLOR AND DEFORMITY AT THE END OF THE PLUNGER" "THE COLOR VARIATION WAS NOTICED BEFORE OPENING THE PACKAGE., THERE WAS NO DIRECT CONTACT WITH THE MEDICINE. COLOR: REDDISH BROWN. MATERIAL NOT USED. "

    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 SER PLASTIPAK 1MLS TUB PDR1400 PLUNGER WAS FOUND DEFORMED AND DISCOLORED TO A "REDDISH BROWN" BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN PRODUCING LIQUEMINE WITH THE PLASTIPAK TURBECULIN SYRINGE (REF: 990189), IT WAS NOTICE THE PRESENCE OF ATYPICAL COLOR AND DEFORMITY AT THE END OF THE PLUNGER" "THE COLOR VARIATION WAS NOTICED BEFORE OPENING THE PACKAGE., THERE WAS NO DIRECT CONTACT WITH THE MEDICINE. COLOR: REDDISH BROWN. MATERIAL NOT USED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770089 SER PLASTIPAK 1MLS TUB PDR1400 PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8145659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other