BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 10 ML

    MDR report key: 14744331 · Received June 20, 2022

    Report

    Report Number
    1213809-2022-00346
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THREE PHOTOS OF 10ML SLIP-TIP SYRINGES (P/N 303134) BATCH 1013522 IN A BLISTERPACK WERE RECEIVED AND EVALUATED. ONE IMAGE SHOWS TWO SEALED PACKAGES WITH THE TOP WEB GRAPHICS SHOWING ALL APPLICABLE INFORMATION. OTHER TWO IMAGES SHOW A BLACK BEETLE BUG INSECT THE SIZE OF THE PLUNGER ROD THUMBREST OBSERVED OUTSIDE OF THE FLUID PATH LAYING ON TOP OF THE PLUNGER ROD THUMBREST. ONE IMAGE SHOWS A CLOSE-UP OF THE BEETLE BUG AND THE OTHER IMAGE SHOWS TWO SEALED PACKAGES NEXT TO ONE ANOTHER WITH THE INSECT IN ONE OF THEM WITH MANY BLACK PARTICULATES, COMPOSITION OF FOREIGN MATTER CANNOT BE DETERMINED BASED UPON THE PHOTOS RECEIVED. THE BLISTER PACKAGE WAS SEALED IN THE PHOTOS AND PHYSICALLY DID NOT HAVE ANY TEARS OR HOLES INDICATING THE INSECT HAD WORKED ITS WAY INTO THE PACKAGE. THE SYRINGE RECEIVED WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT MAY BE ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. SINCE THE INSECT WAS INSIDE THE SYRINGE OUTSIDE OF THE FLUID PATH IT IS MOST LIKELY ENTERED AFTER ASSEMBLY BUT PRIOR TO THE IN-LINE PACKAGING PROCESS. BD CANAAN MAINTAINS A ROBUST PEST CONTROL PROGRAM THAT INCLUDES STRATEGICALLY PLACED INSECT LIGHT TRAPS THROUGHOUT THE FACILITY. INTERIOR INSECT CONTROL IN COMBINATION WITH EXTERIOR INSECT CONTROL BY A THIRD PARTY HELPS TO ENSURE THE MAXIMUM AMOUNT OF CONTAINMENT FOR ANY PESTS THAT MAY ATTEMPT TO ENTER THE FACILITY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1013522. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 10 ML EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND A BEETLE PACKAGED INSIDE THE BD 10ML SLIP TIP SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 10 ML EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND A BEETLE PACKAGED INSIDE THE BD 10ML SLIP TIP SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2814295 BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 10 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1013522

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown