BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9535570 · Received December 31, 2019

    Report

    Report Number
    9616657-2019-00391
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 16, 2019
    Report Date
    January 3, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED 32GX4MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED. CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION. THE RETURNED PEN NEEDLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BENT. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT NPE CANNULA WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLE, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLE WAS CLOGGED. SINCE THE PEN NEEDLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULA IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR.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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO. 320122. BATCH NO. 9113866. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLES THE NEEDLE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE DOES NOT PRIME BEFORE USE STATED, HE WAS TOLD TO ONLY PRIME ONCE WHEN HE STARTS A NEW PEN. ONLY REPORTING 1 BOX/1 LOT 2 PEN NEEDLES AFFECTED ON: (B)(6). STATED, 30% OF BOX AFFECTED BUT HE CAN ONLY PROVIDE TWO INCIDENT DATES LOT: 9113866 ITEM: 320122 EXPIRATION DATE: 2024-05-31 LOT: 9113866 CL

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 320122 BATCH NO. 9113866. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLES THE NEEDLE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE DOES NOT PRIME BEFORE USE. STATED, HE WAS TOLD TO ONLY PRIME ONCE WHEN HE STARTS A NEW PEN. ONLY REPORTING 1 BOX/1 LOT. 2 PEN NEEDLES AFFECTED ON: (B)(6) 2019. STATED, 30% OF BOX AFFECTED BUT HE CAN ONLY PROVIDE TWO INCIDENT DATES. LOT: 9113866. ITEM: 320122. EXPIRATION DATE: 2024-05-31. LOT: 9113866 CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331519 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 2865 9113866 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other