BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10135603 · Received June 9, 2020

    Report

    Report Number
    1911916-2020-00540
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. THE PHOTO SHOWS THE PACKAGING BLISTER TOP WEB AND THE BOTTOM PART OF A SYRINGE, THE SYRINGE HAS BEEN USED. IT HAS A TIP CAP. IT HAS A FOREIGN MATTER LIKE HAIR PLASTIC OF ABOUT 3/8¿ LONG. IT HAS ADHERED TO THE INNER WALL OF THE SYRINGE BARREL. EVEN THOUGH THE PRESENCE OF FOREIGN MATTER IS CONFIRMED, THE SOURCE IS UNKNOWN. THE SYRINGE HAS BEEN USED. FURTHERMORE, A PHYSICAL SAMPLE WOULD BE HELPFUL TO FULLY INVESTIGATE AND CONFIRM THE TYPE OF FOREIGN MATTER AND POSSIBLY THE SOURCE. AT THIS TIME NO FURTHER ACTIONS ARE TAKEN. HOWEVER, MONITORING OF THIS LOT WILL BE PERFORMED FOR THIS TYPE OF SYMPTOM. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 62310 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: ROOT CAUSE COULD NOT BE DETERMINED. EVEN THOUGH THE PRESENCE OF FOREIGN MATTER IS CONFIRMED, THE SOURCE IS UNKNOWN. THE SYRINGE HAS BEEN USED. FURTHERMORE, A PHYSICAL SAMPLE WOULD BE HELPFUL TO FULLY INVESTIGATE AND CONFIRM THE REPORTED CONDITION. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "PLASTIC HAIR" WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PHARMACIST REPORTED TO HIM THERE WAS A "PLASTIC HAIR" IN SYRINGE 309653 LOT 0062310 FOUND AROUND 5:00 PM ON (B)(6)2020. PHARMACIST TOOK A PHOTO OF IT DID NOT KNOW IF THEY STILL HAD THE SYRINGE OR IF ANYONE WAS HARMED WHEN IT WAS DISCOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600179 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062310 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other