BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 10909700 · Received November 26, 2020

    Report

    Report Number
    1911916-2020-01067
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9182626. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION, A PICTURE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INSPECTION. THE PICTURE SHOWS A PLUNGER ROD THUMB PRESS DAMAGED. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE ASSEMBLY PROCESS WHERE A JAM OCCURRED AT THE PLUNGER ROD-RUBBER STOPPER ASSEMBLY, INDUCING THE DAMAGE TO THE PLUNGER ROD THUMB PRESS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE PROVIDED THE SYMPTOM REPORTED BY THE CUSTOMER WAS CONFIRMED. ROOT CAUSE DESCRIPTION: IT COULD BE POSSIBLE THAT A JAM OCCURRED AT THE PLUNGER ROD- RUBBER STOPPER ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE PLUNGER ROD THUMB PRESS. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE PLUNGER WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SYRINGE WITH BROKEN PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377601 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9182626

    Patients

    Seq Age Sex Outcome Treatment
    1