BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE MINI

    MDR report key: 11285634 · Received February 5, 2021

    Report

    Report Number
    9616656-2021-00118
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF BD SHELF CARTONS AND 31GX5MM BD PEN NEEDLES WAS PROVIDED. THE CUSTOMER REPORTED THAT FOR 5 DIFFERENT BATCHES AT LEAST ONE NEEDLE WAS CLOGGED. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT OPENED BD SHELF CARTONS DISPLAYING LOT INFORMATION WAS SHOWN ALONGSIDE 31GX5MM BD PEN NEEDLES. FROM THE PHOTO ALONE IT COULD NOT BE DETERMINED IF THE PEN NEEDLES WERE CLOGGED. NO DEFECTS WERE OBSERVED, THEREFORE THE ALLEGED ISSUE COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 32 BD ULTRA-FINE¿ PEN NEEDLES MINI WERE UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT INFORMS THAT USES THE BD ULTRA-FINE 5MM NEEDLES TO APPLY INSULIN, AND REPORTED THAT THIS WAS THE THIRD TIME SHE COMPLAINTS REGARDING THE SAME ISSUE. INFORMED 5 DIFFERENT BATCHES FROM SAME NEEDLE LENGTH. REPORTING THAT IN ALL BATCHES AT LEAST MORE THAN ONE NEEDLE HAVE COME CLOGGED. IN TOTAL, MORE THAN 30 NEEDLES FROM DIFFERENT BATCHES. THE PATIENT PERFORMS THE FLOW TEST AND DOES NOT REUSE THE NEEDLES, SHE PERFORMS ALL THE PREPARE AND APPLICATION PROCEDURES PROPERLY. INFORMED THAT THE NEEDLES SEEM NORMAL, BUT WHEN TESTING THE LIQUID DOES NOT GO THROUGH THEM. IN OTHER WORDS, THEY ARE COMPLETELY CLOGGED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8149866. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-05-29. MEDICAL DEVICE LOT #: 9022899. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-22. MEDICAL DEVICE LOT #: 9046867. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-15. MEDICAL DEVICE LOT #: 9204830. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-07-23. MEDICAL DEVICE LOT #: 9044761. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-13. MEDICAL DEVICE LOT #: 8107719. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-17. MEDICAL DEVICE LOT #: 9204831. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-07-23. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 32 BD ULTRA-FINE¿ PEN NEEDLES MINI WERE UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT INFORMS THAT USES THE BD ULTRA-FINE 5MM NEEDLES TO APPLY INSULIN, AND REPORTED THAT THIS WAS THE THIRD TIME SHE COMPLAINTS REGARDING THE SAME ISSUE. INFORMED 5 DIFFERENT BATCHES FROM SAME NEEDLE LENGTH. REPORTING THAT IN ALL BATCHES AT LEAST MORE THAN ONE NEEDLE HAVE COME CLOGGED. IN TOTAL, MORE THAN 30 NEEDLES FROM DIFFERENT BATCHES. THE PATIENT PERFORMS THE FLOW TEST AND DOES NOT REUSE THE NEEDLES, SHE PERFORMS ALL THE PREPARE AND APPLICATION PROCEDURES PROPERLY. INFORMED THAT THE NEEDLES SEEM NORMAL, BUT WHEN TESTING THE LIQUID DOES NOT GO THROUGH THEM. IN OTHER WORDS, THEY ARE COMPLETELY CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182286 BD ULTRA-FINE PEN NEEDLE MINI PEN NEEDLE FMI BECTON DICKINSON AND CO. 9204831

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR