BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 12964055 · Received December 8, 2021

    Report

    Report Number
    1911916-2021-01235
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A FOREIGN PIECE OF PLASTIC WAS FOUND IN A SYRINGE BARREL. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE OUT OF THE PACKAGING BLISTER. THE SYRINGE HAS A PIECE OF PLASTIC INSIDE AT THE BOTTOM THAT APPEARS TO BE A PIECE FROM A BARREL FLANGE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING PRODUCTION RIGHT BEFORE THE PLUNGER ROD-RUBBER STOPPER WAS ASSEMBLED TO THE SYRINGE BARREL. A PIECE OF PLASTIC FROM A DAMAGED SYRINGE BARREL COULD HAVE ENDED UP IN THE UNIT REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1091267. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. ALIGNMENT OF THE RAILS AND CONVEYORS WAS GOOD. THE SETTING OF THE EQUIPMENT WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT A PIECE OF PLASTIC WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I FOUND AN EXTEMPORANEOUS PIECE OF PLASTIC IN THE BARREL OF A 20ML SYINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I FOUND AN EXTEMPORANEOUS PIECE OF PLASTIC IN THE BARREL OF A 20ML SYINGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856800 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1091267 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown