BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE

    MDR report key: 12421958 · Received September 3, 2021

    Report

    Report Number
    9616656-2021-01090
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN ADDED: D.10 DEVICE RETURNED TO MANUFACTURER?: YES D.10 DATE RETURNED TO MANUFACTURER?: 2021-10-21 H.3 DEVICE RETURNED TO MANUFACTURER?: YES H.3. DEVICE EVAL BY MANUFACTURER?: YES SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED 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 NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME. H.6 INVESTIGATION CONCLUSION: TWENTY SEVEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1062594, CAT. NO. 320141. A CLOG TEST WAS CARRIED OUT ON ALL TWENTY SEVEN SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR PATIENTS HAS REPORTED HAVING PROBLEMS WITH THE BD MICRO-FINE ULTRA NEEDLES, 4MM. IT HAPPENS WITH REGULARITY THAT THE NEEDLE SEEMS TO BE "CLOGGED" AND THEREFORE NO INSULIN COMES OUT. IT IS NOT BECAUSE OF THE INSULIN PEN. CONSUMER HAS USED SEVERAL BOXES OF NEEDLES AND EACH TIME SHE RUNS INTO THIS PROBLEM. THERE ARE GOOD NEEDLES IN THERE, BUT ALSO BAD ONES. WE HAVE NOT HEARD ANY COMPLAINTS FROM OTHER PATIENTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR PATIENTS HAS REPORTED HAVING PROBLEMS WITH THE BD MICRO-FINE ULTRA NEEDLES, 4MM. IT HAPPENS WITH REGULARITY THAT THE NEEDLE SEEMS TO BE "CLOGGED" AND THEREFORE NO INSULIN COMES OUT. IT IS NOT BECAUSE OF THE INSULIN PEN. CONSUMER HAS USED SEVERAL BOXES OF NEEDLES AND EACH TIME SHE RUNS INTO THIS PROBLEM. THERE ARE GOOD NEEDLES IN THERE, BUT ALSO BAD ONES. WE HAVE NOT HEARD ANY COMPLAINTS FROM OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318854 BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 1062594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown