BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL W/NDL 20X1-1/2 RB

    MDR report key: 9868325 · Received March 23, 2020

    Report

    Report Number
    1213809-2020-00197
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096450
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : TWO PHOTOS OF BLISTER PACKS (P/N 309645) WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A FULLY SEALED BLISTER PACK FROM BATCH 5246743. ONE PHOTO DISPLAYED THREE BLISTER PACKS WITH ONE FROM BATCH 7060550, ONE FROM BATCH 9143661, AND ONE UNKNOWN. THE DIFFERENT GRAPHICS AND/OR INFORMATION BETWEEN THE PACKAGES SHOWN IN THE PHOTOS IS DUE TO CHANGES IN FDA REQUIREMENTS. THE FIRST CHANGE OCCURRED IN 2016, IN WHICH THE UDI MUST INCLUDE THE EXPIRATION DATE AS SHOWN ON THE PACKAGE FROM BATCH 7060550. THE SECOND CHANGE OCCURRED IN 2018, IN WHICH THE UDI MUST INCLUDE THE PRODUCT INFORMATION AS A 2D BARCODE AS SHOWN ON PACKAGE FROM BATCH 9143661. ALL THE PACKAGES SHOWN WERE IN COMPLIANCE WITH THE LABELLING REQUIREMENTS AT THE TIME OF MANUFACTURE. ADDITIONALLY, THE PRODUCTS HAVE A 5-YEAR EXPIRATION WINDOW. BATCH 5246743 EXPIRES 8/31/2020. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTOS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5246743. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 SYRINGES 10ML LL W/NDL 20X1-1/2 RB EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309645 BATCH NO.: 5246743. SYRINGES MISSING EXPIRATION DATE AND LOT NUMBERS MISSING NUMBERS/ HARD TO READ.

    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 10 SYRINGES 10ML LL W/NDL 20X1-1/2 RB EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309645, BATCH NO.: 5246743. SYRINGES MISSING EXPIRATION DATE AND LOT NUMBERS MISSING NUMBERS/ HARD TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334016 SYRINGE 10ML LL W/NDL 20X1-1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309645 5246743 30382903096450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other