BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA

    MDR report key: 21057914 · Received January 2, 2025

    Report

    Report Number
    1213809-2024-01016
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 6, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE NEEDLE HAD SOME FOREIGN MATERIAL GROWING ON IT. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. ONE SAMPLE HAS A PARTICLE OF LUBRICANT WITH DUST ADHERED TO THE NEEDLE LOCATED 1/4" FROM THE NEEDLE HUB. THE OTHER SAMPLE HAS NO VISIBLE DEFECTS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, AFTER AN EQUIPMENT REPAIR OR MAINTENANCE, CLEANING WAS NOT EFFECTIVE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305270, LOT 4214081. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 4214081 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#:305270, BATCH#: 4214081. IT WAS REPORTED THAT THE BD INTEGRA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. COMPLAINT: WE PURCHASE BD INTEGRA SYRINGES FOR ALL OUR VACCINATIONS AND WE HAD AN ISSUE WITH A LOT LAST WEEK. I HAVE PULLED ALL THE SYRINGES WITH THE LOT. THE NEEDLE WAS NOTED TO HAVE SOME FOREIGN MATERIAL/SUBSTANCE GROWING ON IT. THE NURSE PULLING THE VACCINE NOTED IT BEFORE USING THE SYRINGE. IT WAS NOTED ON SEVERAL SYRINGES FROM THE SAME CASE, SO I PULLED THE REMAINING AND DID NOT CHECK ANY FURTHER. DATE OF EVENT 12/6/2024. NO HARM OR MEDICAL INTERVENTION OCCURRED. REF: 305270, LOT#: 4214081. 4 CASES QUARANTINED. ADDITIONAL INFORMATION PROVIDED: 1. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES, I HAVE IT AVAILABLE. ADDRESS: (B)(6). 2. WAS THE FOREIGN MATTER INSIDE THE BARREL? IT WAS ON THE NEEDLE. 3. WAS THE FOREIGN MATTER ON THE CANNULA? IT WAS ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395993 BD INTEGRA SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 4214081 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown