BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS ¿ 31 G × 5 MM PEN INJECTOR NEEDLE

    MDR report key: 6911230 · Received October 3, 2017

    Report

    Report Number
    9616656-2017-00102
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE SEALED 31G X 5MM PEN NEEDLE POLYBAG AND TWO PHOTOS WERE RETURNED FORM LOT. NO. 7032824, CAT. NO. 320129. UPON VISUAL EXAMINATION OF THE RETURNED SAMPLE AND PHOTOS IT WAS OBSERVED THAT ONE 30G X 8MM PEN NEEDLE SAMPLE FROM LOT. NO. 7060958 WAS MIXED IN A 31G X 5MM PEN NEEDLE POLYBAG FROM LOT. NO. 7032824. A NEEDLE THROUGH SHIELD WAS ALSO OBSERVED IN THE POLYBAG ON ONE PEN NEEDLE SAMPLE. NO QN¿S OR NOE¿S RELATED TO THIS FAIL MODE WERE RAISED DURING MANUFACTURE OF THIS LOT. A REVIEW OF THE DHR WAS CARRIED OUT. IN-PROCESS INSPECTIONS WERE REVIEWED AS PER MAN351, NO ISSUES WERE OBSERVED. LINE CLEARANCE WAS REVIEWED AS PER MAN399, NO ISSUES WERE OBSERVED. IT WAS NOTED THAT AT THE TIME THERE WAS A SITE WIDE POWER OUTAGE WHICH MEANT THAT THE AREA WAS VACATED DURING THE EXECUTION OF THE LINE CLEARANCE. FINAL INSPECTIONS WERE REVIEWED AS PER Q-SOP-050-DL-B AND NO ISSUES WERE FOUND. THE ROGUE PEN NEEDLE FROM LOT # 7060958 WAS MANUFACTURED ON PEN NEEDLE LINE 01 (PNL 01) AND PACKAGED ON (B)(4) PACK LINE. THE CORRECT LOT # 7060958 WAS MANUFACTURED ON PEN NEEDLE LINE 15 (PNL 15) AND PACKAGED ON THE (B)(4) PACK LINE. BOTH LOTS WERE PACKAGED IN THE JAPAN PACKAGING AREA. LOT # 7060958 WAS PACKAGED DIRECTLY BEFORE LOT # 7032824. A REVIEW OF CORRECTIVE MAINTENANCE RECORDS FOR JAPAN PACKAGE AREA INDICATES NO MAINTENANCE CARRIED OUT THAT COULD CAUSE THIS DEFECT. PRODUCT MIX THE LINE CLEARANCE WAS INTERRUPTED AS A RESULT OF THE SITE WIDE POWER OUTAGE. THIS MEANT THAT THE LINE CLEARANCE WAS NOT CORRECTLY EXECUTED AND THE ROGUE PEN NEEDLE WAS SUBSEQUENTLY NOT REMOVED FROM THE LINE. NEEDLE THROUGH SHIELD. THE PROBABLE ROOT CAUSE IS THAT THE NEEDLE WAS BENT DURING THE SHIELDING PROCESS. CAPA (B)(4) WILL INCLUDE ACTIONS TO ADDRESS PRODUCT MIX CAPA (B)(4) WAS OPENED FOR NEEDLE THROUGH SHIELD DEFECTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER RECEIVED A BAG OF MIXED PRODUCTS AND ONE OF THE BD MICRO FINE PLUS ¿ 31 G × 5 MM PEN INJECTOR NEEDLE(S) IN THAT BAG WAS PIERCED THROUGH THE OUTER COVER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689149 BD MICRO FINE PLUS ¿ 31 G × 5 MM PEN INJECTOR NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7032824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other