BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

    MDR report key: 19606041 · Received June 25, 2024

    Report

    Report Number
    1920898-2024-00133
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 23, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903055401
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 5 PHOTOS AND 26 TRAYS WERE RECEIVED FOR INVESTIGATION BY OUR QUALITY TEAM. ONE "OPENED" TRAY WAS RECEIVED WITH A SYRINGE CRIMPED AND FUSED INTO THE CORNER WERE THE SEAL MEETS PLASTIC. THE COMPLAINT HAS BEEN VERIFIED AND THE ROOT CAUSE OF THIS ISSUE IS DUE TO IMPROPER TRAY LOADING THAT LED SEAL TO SEAL OTHER A SYRINGE AND CLEAVE IT. THIS ISSUE IS A QUALITY CONTROL DEFICIENCY BECAUSE THE DEFECT SHOULD HAVE BEEN NOTICED DURING VISUAL CHECKS. CORRECTIVE ACTIONS ARE NOT POSSIBLE BECAUSE THE PRODUCTION FACILITY FOR THE DEVICE'S PRODUCTION HAS SINCE CLOSED. NO ISSUE WAS PRESENT IN THE PACKAGING OF ANY OTHER TRAYS. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE (BATCH# 2304613).

    Description of Event or Problem · 0

    MATERIAL# 305540 , BATCH# 2304613. IT WAS REPORTED THAT THE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB PACKAGING WAS DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED A CUSTOMER COMPLAINT ON 23MAY24 FOR 46 TRAYS OF 1CC, 27G X ½, SYRINGES (ITEM# BD5540, LOT# 2304613), STATING ¿SYRINGES ARE MELTED TO PACKAGING¿. THE CUSTOMER RETURNED THE PRODUCT ON (B)(6) 2024. ONE BOX WITH 5 UNOPENED TRAYS AND ONE OPEN TRAY AND ONE CASE CONTAINING 40 UNOPENED TRAYS WERE RETURNED. PLEASE PROVIDE A PREPAID RETURN LABEL TO FORWARD THE REPORTED PRODUCT TO YOU. CAN YOU PLEASE INITIATE AN INVESTIGATION AND FORWARD YOUR FINDINGS TO ME. WE HAVE ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS COMPLAINT. PLEASE REFERENCE THIS COMPLAINT NUMBER IN ALL FUTURE CORRESPONDENCE.

    Description of Event or Problem · 0

    SAMPLES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442023 BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2304613 00382903055401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown