BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 25GA 3/4IN W/O SILICONE

    MDR report key: 8799783 · Received July 17, 2019

    Report

    Report Number
    1911916-2019-00712
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) PHOTO SHOWS A BAG LABEL WHICH HAS HAD PART OF THE LABEL RIPPED OFF. THE SECOND (2ND) PHOTO SHOWS A BAG LABEL WHICH HAS NO PRINT ON THE TOP HALF OF THE LABEL AND HAS BEEN MISPRINTED ON THE BOTTOM HALF. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER BD ACKNOWLEDGES THAT THE BAG IN THE FIRST PHOTO HAS HAD PART OF THE LABEL RIPPED OFF. BASED ON THE PHOTO PROVIDED IT CANNOT BE DETERMINED WHAT CAUSED PART OF THE BAG LABEL TO RIP OFF. THE SECOND (2ND) PHOTO SHOWS A COMPLETE LABEL WHICH HAS BEEN MISPRINTED. IT IS LIKELY THAT THE LABEL WAS MISPRINTED AT THE PRINTER AND WAS PLACED ON THE BAG WITHOUT THE OPERATOR NOTICING THAT IT WAS NOT PRINTED PROPERLY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LABEL CONTENT MISSING FOR LOT #9023758 ITEM #301670. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER BD ACKNOWLEDGES THAT THE BAG IN THE FIRST PHOTO HAS HAD PART OF THE LABEL RIPPED OFF. BASED ON THE PHOTO PROVIDED IT CANNOT BE DETERMINED WHAT CAUSED PART OF THE BAG LABEL TO RIP OFF. THE SECOND (2ND) PHOTO SHOWS A COMPLETE LABEL WHICH HAS BEEN MISPRINTED. IT IS LIKELY THAT THE LABEL WAS MISPRINTED AT THE PRINTER AND WAS PLACED ON THE BAG WITHOUT THE OPERATOR NOTICING THAT IT WAS NOT PRINTED PROPERLY. RATIONALE: BD ACKNOWLEDGES THAT THE PHOTOS PROVIDED BY THE CUSTOMER SHOW A BAG WHICH HAS A LABEL WHICH HAS BEEN RIPPED AND IS MISSING PART AND A SECOND (2ND) BAG WHICH HAS A LABEL WHICH HAS BEEN MISPRINTED. THERE ARE NO SPECIFICATIONS FOR BAG LABEL DAMAGE OR MISPRINT; HOWEVER, AS A MEANS OF RAISING AWARENESS A QUALITY ALERT WILL BE ISSUED TO THE ASSOCIATES INVOLVED IN THE PRODUCTION OF THIS MATERIAL. THIS ALERT WILL BE SHARED AT SHIFT STARTUP TO ALL ASSOCIATES AND THEN WILL BE POSTED FOR ONE (1) WEEK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE NS 25GA 3/4IN W/O SILICONE HAD LABELING ISSUES. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301670, BATCH NO. 9023758. IT WAS REPORTED THAT TWO BAGS WERE IDENTIFIED WITH LABELLING ISSUES. (B)(4) ¿ LABELLING. DATE OF OCCURRENCE: (B)(6) 2019. PART NO: 05-8016, SUSPECT LOT: 9023758. DESCRIPTION: TWO BAGS WERE IDENTIFIED WITH LABELLING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594357 NEEDLE NS 25GA 3/4IN W/O SILICONE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9023758

    Patients

    Seq Age Sex Outcome Treatment
    1 Other