BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLES

    MDR report key: 14370488 · Received May 12, 2022

    Report

    Report Number
    9616656-2022-00529
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 22, 2022
    Report Date
    July 25, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1223670 D4: MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026 H4: DEVICE MANUFACTURE DATE: 11-AUG-2021 D9: DEVICE AVAILABLE FOR EVALUTION?: YES. D9: RETURNED TO MANUFACTURER ON: 05-JUL-2022 H6: INVESTIGATION SUMMARY ONE OPEN 31G X 5 MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 1223670, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND IT WAS OBSERVED THAT THE TEAR DROP LABEL WAS NOT ATTACHED TO THE PEN NEEDLE AND THERE IS NO EVIDENCE OF A HEAT SEAL BEING APPLIED. A LOT HISTORY REVIEW WAS CARRIED OUT AND ONE RELATED NON CONFORMANCE WAS IDENTIFIED. THE PROCESS WAS CORRECTED, AND SAMPLING PERFORMED AS PER APPLICABLE QC SPECIFICATIONS. AQL SAMPLING WAS PERFORMED, AND NO FURTHER DEFECTS WERE OBSERVED. THE MOST PROBABLE ROOT CAUSE OF THIS ISSUE WAS DUE TO FAILING/SEIZING COMPLIANCE PINS THAT PUSH THE PEN NEEDLE PARTS UP DURING TEARDROP LABEL SEALING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PEN NEEDLE EXPERIENCED A DAMAGED TEAR DROP LABEL WHERE THE STERILITY OF THE PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEAR DROP LABEL WAS FOUND TO BE SEPARATED BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PEN NEEDLE EXPERIENCED A DAMAGED TEAR DROP LABEL WHERE THE STERILITY OF THE PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEAR DROP LABEL WAS FOUND TO BE SEPARATED BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PEN NEEDLE EXPERIENCED A DAMAGED TEAR DROP LABEL WHERE THE STERILITY OF THE PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEAR DROP LABEL WAS FOUND TO BE SEPARATED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083849 BD MICRO-FINE¿+ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1223670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown