BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA

    MDR report key: 9482591 · Received December 17, 2019

    Report

    Report Number
    3003916417-2019-00632
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 26, 2019
    Report Date
    January 8, 2020
    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

    H.6. INVESTIGATION: DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS WERE PERFORMED AND NO OCCURRENCES POTENTIALLY RELATED TO THE DEFECT WAS OBSERVED. THE SAMPLES PROVIDED BY THE CUSTOMER FOR THE BATCH 9190268 WERE EVALUATED AND IT IS POSSIBLE TO OBSERVE PLUNGER ACTIVATED AT BLISTER IN 4 SAMPLES AND 1 SAMPLE WITH ACTIVATED PLUNGER HOWEVER THE PACKAGING WAS OPENED IN A WAY THAT COULD LED TO THE PREMATURE PLUNGER ACTIVATION. THE SAMPLE PROVIDED BY THE CUSTOMER FOR THE BATCH 9135601 WERE EVALUATED AND IT IS POSSIBLE OBSERVE PLUNGER ACTIVATED AT BLISTER IN 1 SAMPLE. THE POTENTIAL CAUSE FOR THE OCCURRENCE IS A JAM AT ASSEMBLY PROCESS, LEADING TO THE PREMATURE ACTIVATION. ANOTHER POTENTIAL ROOT CAUSE IS A WEAKENING AT PLUNGER MOLDING CAUSING THE ACTIVATION FORCE LOW. WAS PERFORMED THE PLUNGER ACTIVATION FORCE TEST AT BATCH RELEASE AND NO DEVIATION WERE OBSERVED FOR THE COMPLAINT BATCH. ALSO, IS NECESSARY CHECK THE CUSTOMER PRODUCT USAGE AS THE BREAKABLE PLUNGER IS PART OF PRODUCT FUNCTION TO PREVENT SYRINGE REUSAGE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER WAS DISCOVERED TO BE BROKEN PRIOR TO USE WITH A BD SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: ALL SYRINGES CAME WITH A BROKEN PLUNGER.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9135601. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-23. MEDICAL DEVICE LOT #: 9190265. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-22." 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 PLUNGER WAS DISCOVERED TO BE BROKEN PRIOR TO USE WITH A BD SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: ALL SYRINGES CAME WITH A BROKEN PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280136 BD SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other