BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9711477 · Received February 14, 2020

    Report

    Report Number
    9616656-2020-00115
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 20, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 SAMPLES WERE RECEIVED, CUSTOMER RETURNED (10) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED FINDING PEN NEEDLES CLOGGED DURING FLOW CHECK, ALSO FOUND THESE SAME 10 PEN NEEDLE TO HAVE NON PATIENT END BENT. ALL 10 RETURNED PEN NEEDLES WERE EXAMINED AND IT WAS OBSERVED THAT ALL 10 HAD BENT NON-PATIENT END (NPE) CANNULAS. THIS IS THE 3RD RELATED COMPLAINT FOR NEEDLE CLOG & THE 1ST RELATED COMPLAINT FOR NEEDLE BENDING DURING USE NPE FOR THE REPORTED LOT NUMBER. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED PEN NEEDLES. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL 10 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9162522 TWO COMPLAINTS WERE CREATED BECAUSE OF EACH PEN NEEDLE WAS MANUFACTURED IN DIFFERENT MANUFACTURING SITE. IT WAS REPORTED THAT THE CUSTOMER WAS FINDING PEN NEEDLES CLOGGED DURING FLOW CHECK. WHILE ON THE PHONE FOUND THESE SAME 10 PEN NEEDLE TO HAVE NON PATIENT END BENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9162522. TWO COMPLAINTS WERE CREATED BECAUSE OF EACH PEN NEEDLE WAS MANUFACTURED IN DIFFERENT MANUFACTURING SITE. IT WAS REPORTED THAT THE CUSTOMER WAS FINDING PEN NEEDLES CLOGGED DURING FLOW CHECK. WHILE ON THE PHONE FOUND THESE SAME 10 PEN NEEDLE TO HAVE NON PATIENT END BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178018 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 9162522 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other