BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT 5 MICRON FILTER NEEDLE 18 G X 1 1/2 IN

    MDR report key: 15183087 · Received August 8, 2022

    Report

    Report Number
    1911916-2022-00408
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: IT WAS REPORTED THERE WAS SOMETHING GREEN IN THE SYRINGE THAT LOOKS LIKE A PIECE OF PLASTIC. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A BAYER SHELF BOX. THE OTHER PHOTO SHOWS A SYRINGE WITH A NEEDLE ASSEMBLY, INCLUDING THE PLASTIC SHIELD, CONNECTED TO IT. THE PRODUCT SHOWN IN THE PHOTO IS NOT A FILTER NEEDLE. AT THE LUER LOCK AREA OF THE SYRINGE BARREL THERE IS A RED CIRCLE INDICATING WHERE THE FOREIGN MATTER IS. THE PHOTO HAS A NOTE STATING THERE IS A GREEN SPECK. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT NUMBER 7200624. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ BLUNT 5 MICRON FILTER NEEDLE 18 G X 1 1/2 IN HAD FOREIGN MATTER IN DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE INJECTING THE PATIENT HE NOTICED THERE WAS SOMETHING GREEN IN THE SYRINGE THAT LOOKS LIKE A BIT OF PLASTIC. HE DID NOT INJECT THE PATIENT AND SENT THE SYRINGE BACK TO THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245416 BD¿ BLUNT 5 MICRON FILTER NEEDLE 18 G X 1 1/2 IN MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7200624 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown