BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 12757047 · Received November 7, 2021

    Report

    Report Number
    1213809-2021-00751
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO PHOTOS AND A 5ML SYRINGE (P/N 309646) IN A PARTIALLY OPENED BLISTERPAK FROM BATCH #1152421 WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. IT WAS IMMEDIATELY OBSERVED THAT FOREIGN MATTER WAS PRESENT OUTSIDE OF THE FLUID PATH STUCK BETWEEN THE BARREL WALL AND PLUNGER RIBS. THE FOREIGN MATTER WAS A DECEASED FOUR-WINGED ANT-LIKE INSECT. 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. BD (B)(4) 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. 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 LIKELY THAT IT ENTERED AFTER ASSEMBLY, BUT PRIOR TO THE IN-LINE PACKAGING PROCESS. THIS DEFECT WILL BE COMMUNICATED TO THE MANUFACTURING TEAM IN THE FORM OF A QUALITY ALERT. DUE: 01/31/2022. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED FM - INSECT. VERBATIM: PRODUCT NAME AND/OR CATALOG NUMBER 5 ML BD SYRINGE. ANY INJURIES AND/OR HARM? NOT TO OUR KNOWLEDGE. WHAT IS THE ISSUE YOU EXPERIENCED? BUG (DEAD) INSIDE OF SYRINGE INSIDE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660440 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1152421 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown