BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27X1/2 RB

    MDR report key: 11509209 · Received March 17, 2021

    Report

    Report Number
    1911916-2021-00217
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS (B)(6)..  INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305109 AND LOT NUMBER 3241374. ALTHOUGH AT THE TIME THIS PRODUCT WAS PRODUCED THERE WAS NO REQUIREMENT TO HAVE THE EXPIRATION DATE IN THE PACKAGING, 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. BASED ON THE INVESTIGATION WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. AT THE TIME THIS PRODUCT WAS PRODUCED THERE WAS NO REQUIREMENT TO HAVE THE EXPIRATION DATE IN THE PACKAGING. THIS PRODUCT HAS ALREADY EXPIRED. IT IS RECOMMENDED THAT MARKETING CONTACTS THE CUSTOMER TO MAKE THEM AWARE OF HAVING EXPIRED PRODUCTS. IF POSSIBLE ALSO RECOMMEND THE CUSTOMER TO VERIFY THE REST OF THEIR INVENTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 27X1/2 RB EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REPORTED NO EXPIRATION DATE ON BOX OF SYRINGES. TRADEMARK DATE OF 2011. ADVISED THAT THESE SYRINGES WOULD BE EXPIRED. LOT # 3241374, CAT# 305109. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405279 NEEDLE 27X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3241374

    Patients

    Seq Age Sex Outcome Treatment
    1