BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11269992 · Received February 2, 2021

    Report

    Report Number
    1911916-2021-00076
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832 AND LOT NUMBER 0163092. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHYSICAL SAMPLE AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SAMPLE CAME IN AN OPEN PACKAGING BLISTER AND HAS THE SCALE PRINT SKEWED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION WITH THE SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. ROOT CAUSE DESCRIPTION: IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE PRINTING PROCESS. IT MAY HAVE BEEN THAT A JAM OCCURRED INDUCING THE SKEWED PRINTED SCALE MARKINGS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK" TIP SYRINGE SCALE WAS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRONG OF TICK PRINT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162938 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0163092 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1