BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    MDR report key: 13172117 · Received January 5, 2022

    Report

    Report Number
    2243072-2021-03039
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 8, 2021
    Report Date
    May 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    10885403897504
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. MEDICAL 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D1: MEDICAL DEVICE BRAND NAME BD ULTRA-FINE¿ MINI PEN NEEDLE. D3: MEDICAL DEVICE MANUFACTURER BECTON DICKINSON MEDICAL (SINGAPORE). D4 UDI: (B)(4). D4. MEDICAL DEVICE LOT #: 2025239. D4. MEDICAL DEVICE EXPIRATION DATE: 30JUN2024. H4. DEVICE MANUFACTURE DATE: 28JUN2019. G1: G1: MANUFACTURING LOCATION BECTON DICKINSON MEDICAL (SINGAPORE). G5: PMA/510(K)# K213478. D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 31DEC2021. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. BASED ON TREND ANALYSIS, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD MINI PEN NEEDLES, THE DEVICE EXPERIENCED THE INABILITY TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I RECEIVED A PHONE CALL FROM A XXXXXXXX, STATING THAT OVER THE PAST TWO YEARS SHE HAS HAD ISSUES WITH THE MINI PEN NEEDLES. THE ISSUE IS WHEN SHE IS PRIMING THE PEN NEEDLE NOTHING COMES OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ MINI PEN NEEDLE , THE DEVICE EXPERIENCED THE INABILITY TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I RECEIVED A PHONE CALL FROM A (B)(6), STATING THAT OVER THE PAST TWO YEARS SHE HAS HAD ISSUES WITH THE MINI PEN NEEDLES. THE ISSUE IS WHEN SHE IS PRIMING THE PEN NEEDLE NOTHING COMES OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31659 BD ULTRA-FINE¿ MINI PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9165998 10885403897504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female