BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 5 BAG 50 BOX SAMPLE

    MDR report key: 10026837 · Received May 5, 2020

    Report

    Report Number
    9610847-2020-00147
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    UDI-DI
    10885403812002
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MATERIAL 320149 WITH LOT NUMBER 7268675 WERE PACKAGED ON OCTOBER 23, 2017 WITH ORDER QUANTITY OF 446,000 EA. DHR WAS REVIEWED FOR THIS LOT NUMBER AND THERE ARE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE DURING THIS ORDER. THE FOLLOWING MANUFACTURING LOTS OF PEN NEEDLE WERE PACKAGED IN THE LOT REPORTED: MATERIAL : 320148, LOT: 7101670 MATERIAL : 320148, LOT: 7095650 MATERIAL : 320148, LOT: 7088942 MATERIAL : 320148, LOT: 7109984 MATERIAL : 320148, LOT: 7123823 RECEIVING INSPECTION RECORDS WERE REVIEW FOR LOTS LISTED ABOVE OF PEN NEEDLE MATERIAL, AND NO ISSUES WERE REPORTED. THERE WERE NO SAMPLES OR PHOTOS PROVIDED FOR EVALUATION BD NOGALES WAS NOT ABLE TO CONFIRM OR ASSOCIATE TO THE MANUFACTURING PROCESS THE INDICATED FAILURE MODE SINCE NO SAMPLES OR PHOTOS WERE PROVIDED TO OBSERVE THE INDICATED FAILURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM 5 BAG 50 BOX SAMPLE WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320149 BATCH NO.: UNKNOWN (PROVIDED 5205405) IT WAS REPORTED THAT THERE WAS NO INSULIN FLOW ON APPROXIMATELY 20-30 PEN NEEDLES. ADDITIONALLY, IT WAS REPORTED THAT SOME OF THE NEEDLES ARE BENT ON THE PE DURING INJECTIONS. VERBATIM: CONSUMER REPORTED NO INSULIN FLOW ON APPROXIMATELY 20-30 PEN NEEDLES FROM CURRENT BOX. STATED EVERYDAY SHE HAS TO USE A SECOND PEN NEEDLE TO COMPLETE HER INJECTION. STATED SHE ALWAYS CHECKS BOTH ENDS OF THE PEN NEEDLE TO MAKE SURE THE NEEDLE IT IS STRAIGHT. STATED SOME OF NEEDLES ON THE PE ARE BENT DURING INJECTIONS. ALSO STATED SHE DOES NOT PRIME BEFORE HER INJECTIONS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 PEN NDL 32G 4MM 5 BAG 50 BOX SAMPLE WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320149, BATCH NO.: UNKNOWN (PROVIDED 5205405). IT WAS REPORTED THAT THERE WAS NO INSULIN FLOW ON APPROXIMATELY 20-30 PEN NEEDLES. ADDITIONALLY, IT WAS REPORTED THAT SOME OF THE NEEDLES ARE BENT ON THE PE DURING INJECTIONS. VERBATIM: CONSUMER REPORTED NO INSULIN FLOW ON APPROXIMATELY 20-30 PEN NEEDLES FROM CURRENT BOX. STATED EVERYDAY SHE HAS TO USE A SECOND PEN NEEDLE TO COMPLETE HER INJECTION. STATED SHE ALWAYS CHECKS BOTH ENDS OF THE PEN NEEDLE TO MAKE SURE THE NEEDLE IT IS STRAIGHT. STATED SOME OF NEEDLES ON THE PE ARE BENT DURING INJECTIONS. ALSO STATED SHE DOES NOT PRIME BEFORE HER INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486873 PEN NDL 32G 4MM 5 BAG 50 BOX SAMPLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8120 7268675 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other