BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 18803528 · Received February 28, 2024

    Report

    Report Number
    1213809-2024-00122
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 7, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. LOT NUMBERS: 1200435; 3312340; 3306029.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE AND FIVE PHOTOS OF A 10ML LUER-LOK SYRINGE WERE RECEIVED AND EVALUATED. THE SAMPLE WAS RECEIVED LOOSE WITH DECONTAMINATED WITH THE PLUNGER ROD REMOVED FROM THE BARREL. THE FOREIGN MATTER PARTICULATE WAS NOT RECEIVED WITH THE SAMPLE. ALL PHOTOS FROM VARIOUS ANGLES SHOW ONE LOOSE SYRINGE WITH AN UNKNOWN WHITE WITH BLACK MARKINGS PARTICULATE LARGER THAN LEVEL 4 INSIDE THE FLUID PATH ALSO CONTAINING AN UNKNOWN CLEAR FLUID. FTIR ANALYSIS STATES THE MOST LIKELY MATCH TO BE SILICONE USED IN THE MANUFACTURE OF SYRINGES. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1200435 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTE IT WAS REPORTED BY THE CUSTOMER THAT FOUND FOREIGN MATTER IN ONE OF THEIR SYRINGES. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER FOUND FOREIGN MATTER IN ONE OF THEIR SYRINGES. NOT SURE WHICH LOT IT CAME FROM. CUSTOMER IS SENDING IN PICTURES TO THE COMPLAINTS BOX.

    Description of Event or Problem · 0

    MATERIALS#: 309605 BATCH#: 1200435, 3306029. IT WAS REPORTED BY THE CUSTOMER THAT FOUND FOREIGN MATTER IN ONE OF THEIR SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER FOUND FOREIGN MATTER IN ONE OF THEIR SYRINGES. REF NUMBER: 309605; LOT NUMBERS: 1200435; 3312340; 3306029 - NOT SURE WHICH LOT IT CAME FROM. CUSTOMER IS SENDING IN PICTURES TO THE COMPLAINTS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896718 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3306029 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown