BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 16574187 · Received March 20, 2023

    Report

    Report Number
    9610847-2023-00064
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-APR-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGES HAD SMALL PARTICLES IN THEM. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND 20X MAGNIFICATION. NO FOREIGN MATTER WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309703, LOT 2171751. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA. AN ADDITIONAL DEVICE HISTORY WAS REVIEWED FOR THE BATCH OF SYRINGES USED IN THE MANUFACTURING OF THIS PACK. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. THE LOT WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE INVESTIGATION, BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF 191 SYRINGES FROM BD MATERIAL 309703 BATCH WERE FOUND TO HAVE SMALL PARTICLES IN THEM. INSPECTORS DESCRIBE THIS PARTICLE AS A TINY PLASTIC SHAVING, OFTEN IN A CRESCENT SHAPE. SAMPLES ARE AVAILABLE BUT THEY CONTAIN DRUG PRODUCT (ROCURONIUM- PARALYTIC AGENT). THE PARTICLES ARE TOO SMALL TO BE EASILY CAPTURED IN A PICTURE. DATE IN WHICH THE DEFECT OCCURRED OR WAS NOTICED? AND (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF 191 SYRINGES FROM BD MATERIAL: 309703 BATCH WERE FOUND TO HAVE SMALL PARTICLES IN THEM. INSPECTORS DESCRIBE THIS PARTICLE AS A TINY PLASTIC SHAVING, OFTEN IN A CRESCENT SHAPE. SAMPLES ARE AVAILABLE BUT THEY CONTAIN DRUG PRODUCT (ROCURONIUM- PARALYTIC AGENT). THE PARTICLES ARE TOO SMALL TO BE EASILY CAPTURED IN A PICTURE. DATE IN WHICH THE DEFECT OCCURRED OR WAS NOTICED? ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892983 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309703 2171751 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown