BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN-NEEDLE

    MDR report key: 13418842 · Received February 1, 2022

    Report

    Report Number
    9616656-2022-00074
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 06-APR-2022. H6: INVESTIGATION SUMMARY: FOUR OPEN 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1110197, CAT. NO. 320522. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND 2 SAMPLES WERE BENT NON PATIENT END AND 2 SAMPLES WERE BROKEN NON PATIENT END. A FUNCTIONALITY TEST WAS CARRIED OUT AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD ULTRA-FINE PEN-NEEDLES WERE NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST COMPLAINS THAT A CUSTOMER HAD UP TO 4 DEFECTIVE NEEDLES IN EVERY PACK HER CUSTOMER BOUGHT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD ULTRA-FINE PEN-NEEDLES WERE NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST COMPLAINS THAT A CUSTOMER HAD UP TO 4 DEFECTIVE NEEDLES IN EVERY PACK HER CUSTOMER BOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974452 BD ULTRA-FINE PEN-NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1110197

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown