BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ III PEN NEEDLE

    MDR report key: 13759446 · Received March 14, 2022

    Report

    Report Number
    2243072-2022-00341
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 22, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 16-JUN-2022. H6: INVESTIGATION SUMMARY: EIGHT PHOTOS ALONG WITH TWO SEALED PEN NEEDLE POLYBAGS WERE RETURNED FROM LOT. NO. 0294453. VISUAL EXAMINATION OF THE RETURNED POLYBAGS AND SAMPLES WAS CARRIED OUT AND FIVE SEALED MICRO FINE + PEN NEEDLE SAMPLES WERE OBSERVED INSIDE EACH OF THE SEALED POLYBAGS FROM LOT. NO. 0294453. NO MIX OF LOT NUMBERS WAS OBSERVED. THE POLYBAG THE SAMPLES WERE RETURNED IN IS ULTRA-FINE III. ONE SEALED PEN NEEDLE POLYBAG WAS ALSO RETURNED FROM LOT. NO. 1173592 CONTAINING FIVE SEALED MICRO FINE + PEN NEEDLE SAMPLES FROM LOT. NO. 1173592. NO MIX OF LOT NUMBERS WAS OBSERVED. THE POLYBAG THE SAMPLES WERE RETURNED IN IS ULTRA-FINE III. THE POLYBAGS AND THE CARTONS IN THE RETURNED PHOTOS AND SAMPLES ARE NOT USED DURING THE MANUFACTURING PROCESS IN DL. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTOS AND SAMPLES RETURNED THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ III PEN NEEDLE TEAR DROP LABEL HAD THE INCORRECT BRAND NAME ON IT. THIS OCCURRED WITH 50 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS PERTAINING TO SKU 320179. SHELF CARTON AND POUCH HAS BD ULTRA-FINE TM III BRAND NAME. HOWEVER, TEAR DROP LABEL MENTIONS BD MICRO-FINE+, PENTA POINT TECHNOLOGY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ III PEN NEEDLE TEAR DROP LABEL HAD THE INCORRECT BRAND NAME ON IT. THIS OCCURRED WITH 50 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS PERTAINING TO SKU 320179. SHELF CARTON AND POUCH HAS BD ULTRA-FINETM III BRAND NAME. HOWEVER, TEAR DROP LABEL MENTIONS BD MICRO-FINE+, PENTA POINT TECHNOLOGY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278305 BD ULTRA-FINE¿ III PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0245182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown