BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15507699 · Received September 29, 2022

    Report

    Report Number
    9614033-2022-00079
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 5, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    UDI-DI
    00382903023554
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IN THE FIRST IMAGE, IT IS ONLY POSSIBLE TO APPRECIATE A BLUE HUB WITH LOT NUMBER 9091653 WITH A MANUFACTURING DATE OF 2019-04 AND LABELED WITH THE LEGEND RSNOINVIMA2018DM-0017986, SO IT IS NOT POSSIBLE TO FULLY EVALUATE THE PRODUCT. SECOND IMAGE, TWO PRIMARY PACKAGES BLISTER PACK ARE OBSERVED, WITH PRINTED INFORMATION ON THE PRODUCT, HOWEVER, DUE TO THE CLARITY OF THE PHOTOGRAPH, IT IS NOT POSSIBLE TO VISUALIZE THE BATCH NUMBER, ONLY MATERIAL NUMBER 302355. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. IT IS ESSENTIAL TO RECEIVE PHYSICAL SAMPLES TO EVALUATE THE REPORTED DEFECT AND BASED ON THIS EVIDENCE WE CAN CARRY OUT A ROBUST ANALYSIS THAT HELPS US DEFINE IN WHICH PART OF THE PROCESS SOME TYPE OF FINDING COULD HAVE BEEN GENERATED AND TO BE ABLE TO DETERMINE ACTIONS THAT CONTRIBUTE TO THE REDUCTION OF THIS TYPE OF INCIDENT. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES ARRIVED IN THE INCORRECT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CUSTOMER REPORTS THAT THE NEEDLES IN REFERENCE ARRIVE WITH A DIFFERENT PACKAGING.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES ARRIVED IN THE INCORRECT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CUSTOMER REPORTS THAT THE NEEDLES IN REFERENCE ARRIVE WITH A DIFFERENT PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827650 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON DE MEXICO UNKNOWN 00382903023554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown