BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 17927587 · Received October 12, 2023

    Report

    Report Number
    1213809-2023-01137
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 03-NOV-2023 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND 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 CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2320078 D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027 H4. DEVICE MANUFACTURE DATE: 16-NOV-2022 D4. MEDICAL DEVICE LOT #: 2327547 D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027 H4. DEVICE MANUFACTURE DATE: 16-NOV-2022 D4. MEDICAL DEVICE LOT #: 3004043 D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027 H4. DEVICE MANUFACTURE DATE: 04-JAN-2022 H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT: 2320078,(ONE BOX) 2327547,(ONE BOX) 3004043, (TWO BOXES). FOUR BOXES OF PEN NEEDLES IN TOTAL. ASSISTED CONSUMER OVER THE PHONE WITH ATTEMPTING TO PRIME PEN NEEDLES. CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. CATALOG: 320550. DATE OF EVENT: 2023-09-22, 2023-09-20. 6 PEN NEEDLES FAILED TO PRIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT: 2320078,(ONE BOX) 2327547,(ONE BOX) 3004043, (TWO BOXES) FOUR BOXES OF PEN NEEDLES IN TOTAL. ASSISTED CONSUMER OVER THE PHONE WITH ATTEMPTING TO PRIME PEN NEEDLES. CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. CATALOG: 320550 DATE OF EVENT: (B)(6) 2023, (B)(6) 2023 6 PEN NEEDLES FAILED TO PRIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT: 2320078,(ONE BOX) 2327547,(ONE BOX) 3004043, (TWO BOXES) FOUR BOXES OF PEN NEEDLES IN TOTAL. ASSISTED CONSUMER OVER THE PHONE WITH ATTEMPTING TO PRIME PEN NEEDLES. CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. CATALOG: 320550 DATE OF EVENT: (B)(6) 2023, (B)(6) 2023 6 PEN NEEDLES FAILED TO PRIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683626 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown