BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDITII 5ML WITH 23X1

    MDR report key: 11704526 · Received April 21, 2021

    Report

    Report Number
    2243072-2021-01225
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT 2ML AND 5ML 23G FROM LOT # 0123869 AND 0097184, REGARDING ITEM # 300846 WITH THE REPORTED ISSUE THAT ¿2ML AND 5ML DISCARDIT SYRINGES WITH 23G HAVING BARREL DAMAGED, WHEN WE TRY TO ASPIRATE¿. NO SAMPLE AND TWO PHOTOGRAPHS WERE SHARED BY THE CUSTOMER ALONG WITH THE REGISTERED COMPLAINT. THE INVESTIGATING TEAM HAS CARRIED ON THE SIMULATION OF THE DEFECT ON THE RETENTION SAMPLES OF MATERIAL NUMBER 300846 AND 300852 OF LOT NUMBER 0123869 AND 0097184. BASED ON THE PHOTOGRAPH RECEIVED THE DEFECT IS CONFIRMED. THE PROBABLE ROOT CAUSE OF CRACK BARREL IS DUE TO THE PROCESS OF 2ML ONLINE BARREL TRANSFER FROM MOLDING AREA TO THE HOPPER THAT PROCESSES THEM FURTHER TO ASSEMBLY AND PACKAGING. THE CRACKING OF THE BARREL WAS OBSERVED WHILE SIMULATING THIS PROCESS. IT WAS FOUND THAT WHEN COLD BARRELS (STORED IN POLY) ARE MIXED ALONG WITH ONLINE BARRELS, THERE IS A TEMPERATURE VARIATION OF HOT AND COLD BARRELS AS THEY ARE PASSING THROUGH THE PNEUMATIC SHOOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISCARDITII 5ML WITH 23X1 WAS DAMAGED. THIS OCCURRED ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVING BARREL DAMAGED, WHEN WE TRY TO ASPIRATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISCARDITII 5ML WITH 23X1 WAS DAMAGED. THIS OCCURRED ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVING BARREL DAMAGED, WHEN WE TRY TO ASPIRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596475 DISCARDITII 5ML WITH 23X1 SYRINGE FMF BECTON DICKINSON 0097184

    Patients

    Seq Age Sex Outcome Treatment
    1