BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH LUER-LOK TIP

    MDR report key: 9808183 · Received March 9, 2020

    Report

    Report Number
    1911916-2020-00226
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 1 SAMPLE WAS RECEIVED. IT CAME IN AN OPEN PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED. THE BARREL IS DAMAGED AT THE 10ML SCALE MARK. THE DAMAGE WENT THROUGH THE BARREL WALL DAMAGING THE PLUNGER ROD TOO. AFTER THE MOLDING PROCESS THE BARREL GOES FOR PRINTING THE SCALE THEN SILICONE IS APPLIED; AFTER THAT THE PLUNGER-RUBBER STOPPER IS ASSEMBLED. A JAM COULD HAVE OCCURRED DURING THE ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE BARREL AND PLUNGER ROD RIB. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE WITH LUER-LOK¿ TIP WAS FOUND DAMAGED BEFORE USE, WITH PLASTIC ON THE SYRINGE APPEARING "MELTED" AND THE PLUNGER BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A SYRINGE REF (B)(4) THAT APPEARS TO HAVE BEEN DAMAGED IN MANUFACTURING. LOOKS LIKE THE PLASTIC ON THE SYRINGE WAS MELTED AND THE INSIDE PLUNGER IS BROKEN. ONLY ONE I HAVE SEEN. LOT NUMBER 9240598."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD SYRINGE WITH LUER-LOK¿ TIP WAS FOUND DAMAGED BEFORE USE, WITH PLASTIC ON THE SYRINGE APPEARING "MELTED" AND THE PLUNGER BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A SYRINGE REF 302830 THAT APPEARS TO HAVE BEEN DAMAGED IN MANUFACTURING. LOOKS LIKE THE PLASTIC ON THE SYRINGE WAS MELTED AND THE INSIDE PLUNGER IS BROKEN. ONLY ONE I HAVE SEEN. LOT NUMBER 9240598."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267894 BD SYRINGE WITH LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 9240598 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other