BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDITII 2ML WITH 23X1

    MDR report key: 11712796 · Received April 23, 2021

    Report

    Report Number
    2243072-2021-01230
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 1, 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

    H6: INVESTIGATION SUMMARY PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW TWO PHOTOS OF A DISCARDIT 2ML AND 5ML 23G FROM LOT # 0123869 AND 0097184, REGARDING ITEM # 300846 AND 300852 WITH THE REPORTED ISSUE THAT THERE WAS ¿2ML AND 5ML DISCARDIT SYRINGES WITH 23G HAVING BARREL DAMAGED, WHEN WE TRY TO ASPIRATE¿. THE DHR OF LOT NUMBER 0123869 AND 0097184 WAS REVIEWED AND THERE WAS NO QUALITY NOTIFICATION RAISED IN THE DEVICE HISTORY RECORD FROM ITS PRODUCTION INCEPTION TO ITS DISPATCH. 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 CRACKED 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. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISCARDITII 2ML 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 IN AND (B)(4) 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 2ML 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
    614027 DISCARDITII 2ML WITH 23X1 SYRINGE FMF BECTON DICKINSON 0123869

    Patients

    Seq Age Sex Outcome Treatment
    1