BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11646037 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01059
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 US WERE UNABLE TO DELIVER TO MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES WERE BENDING DURING INJECTION AND SHE'S NOT SURE IF SHE'S GETTING HER FULL INJECTION. VERBATIM: EMAIL RECEIVED¿2021-03-15 16:56:13DATE/TIME OF INQUIRY 3/12/2021, 10:16 AM CUSTOMER INQUIRING IF WE HAVE HAD ANY COMPLAINTS ON THE BD NANO 4MM X 32G INSULIN PEN NEEDLES. STATESSHE USES THEM TWICE A DAY AND HAD SOME ISSUES WITH THE LAST TWO BATCHES OF NEEDLES SHE RECEIVED. STATESTHE NEEDLE "BENT" IN HER ARM WHILE SHE WAS TRYING TO GIVE HERSELF INSULIN BUT SHE WAS ABLE TO REMOVE IT. STATESTHIS HAS HAPPENED SEVERAL TIMES AND SHE IS NOT SURE IF SHE IS RECEIVING THE TOTAL DOSE OF HER MEDICATION WHENTHE NEEDLE BENDS. STATES SHE DOES NOT HAVE A REFERENCE NUMBER OR LOT NUMBER." D2: MEDICAL DEVICE BRAND NAME: PEN NDL 32G 4MM HP 100 BOX 1200 US. D4: CATALOG # 320550, D4: LOT # 0203719, D4: UDI # (B)(4), D4: MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. H4: DEVICE MANUFACTURE DATE: 2020-07-21. H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 US WERE UNABLE TO DELIVER TO MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES WERE BENDING DURING INJECTION AND SHE'S NOT SURE IF SHE'S GETTING HER FULL INJECTION. VERBATIM: EMAIL RECEIVED¿2021-03-15 16:56:13DATE/TIME OF INQUIRY 3/12/2021, 10:16 AM CUSTOMER INQUIRING IF WE HAVE HAD ANY COMPLAINTS ON THE BD NANO 4MM X 32G INSULIN PEN NEEDLES. STATESSHE USES THEM TWICE A DAY AND HAD SOME ISSUES WITH THE LAST TWO BATCHES OF NEEDLES SHE RECEIVED. STATESTHE NEEDLE "BENT" IN HER ARM WHILE SHE WAS TRYING TO GIVE HERSELF INSULIN BUT SHE WAS ABLE TO REMOVE IT. STATESTHIS HAS HAPPENED SEVERAL TIMES AND SHE IS NOT SURE IF SHE IS RECEIVING THE TOTAL DOSE OF HER MEDICATION WHENTHE NEEDLE BENDS. STATES SHE DOES NOT HAVE A REFERENCE NUMBER OR LOT NUMBER."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD PEN NEEDLES WERE UNABLE TO DELIVER TO MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES WERE BENDING DURING INJECTION AND SHE'S NOT SURE IF SHE'S GETTING HER FULL INJECTION. VERBATIM: EMAIL RECEIVED (B)(6) 202116:56:13 DATE/TIME OF INQUIRY (B)(6) 2021, 10:16 AM CUSTOMER INQUIRING IF WE HAVE HAD ANY COMPLAINTS ON THE BD NANO 4MM X 32G INSULIN PEN NEEDLES. STATES SHE USES THEM TWICE A DAY AND HAD SOME ISSUES WITH THE LAST TWO BATCHES OF NEEDLES SHE RECEIVED. STATES THE NEEDLE "BENT" IN HER ARM WHILE SHE WAS TRYING TO GIVE HERSELF INSULIN BUT SHE WAS ABLE TO REMOVE IT. STATES THIS HAS HAPPENED SEVERAL TIMES AND SHE IS NOT SURE IF SHE IS RECEIVING THE TOTAL DOSE OF HER MEDICATION WHEN THE NEEDLE BENDS. STATES SHE DOES NOT HAVE A REFERENCE NUMBER OR LOT NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542565 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0203719

    Patients

    Seq Age Sex Outcome Treatment
    1