BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16X1 RB

    MDR report key: 8741903 · Received June 27, 2019

    Report

    Report Number
    1911916-2019-00640
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS THE PRINTED TOP WEB OF FIVE (5) BLISTER PACKS SHOWING THE PRODUCT INFORMATION AND BATCH NUMBER. THERE IS ALSO ONE (1) BLISTER PACK VIEWED THROUGH THE CLEAR BOTTOM WEB SHOWING ONE (1) NEEDLE HUB ASSEMBLY. NO FOREIGN MATTER IS VISIBLE ON THE ONE (1) NEEDLE HUB ASSEMBLY WHICH IS VISIBLE. BASED ON THE INVESTIGATION CONCLUSION, THE CONDITION REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED. 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. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER (FM) FOR LOT #8250779 ITEM #305197. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION, THE CONDITION REPORTED BY THE CUSTOMER BE CONFIRMED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED. AS A CONSEQUENCE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 16X1 RB EXPERIENCED FOREIGN MATTER CONTAMINATION NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305197, BATCH NO: 8250779. VERBATIM: CUSTOMER ASKING IF THERE IS ANY CHANGE IN THE PROCESS OF MANUFACTURING NEEDLES, BECAUSE THEY HAVE PROBLEMS WITH NEEDLES NOW WHICH THEY DIDN'T HAVE BEFORE. BATCHES THAT WE HAVE TECHNICIANS ENDED UP WITH PARTICLES WITH THE PARTICLES IN THE BAG. NOT SURE IF IT WAS SOMETHING INSIDE THE NEEDLE OR SOMETHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531743 NEEDLE 16X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8250779 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other