BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP

    MDR report key: 13586839 · Received February 23, 2022

    Report

    Report Number
    1911916-2022-00097
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    December 10, 2021
    Report Date
    February 28, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WERE MULTIPLE DEFECTS WITH THE PRODUCTS RECEIVED. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. FIVE SAMPLES HAVE EMBEDDED DEGRADED RESIN. THE FIVE PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBER 1180548. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP APPROXIMATELY 241 PIECES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 BATCH NO: 1180548. IT WAS REPORTED BLACK DOTS. BLACK DOTS: 241 PIECES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP APPROXIMATELY 241 PIECES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 BATCH NO: 1180548 . IT WAS REPORTED BLACK DOTS BLACK DOTS: 241 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848537 BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP PISTON SYRNIGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1180548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown