BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 29GA 12.7MM 100 BX 1200 USA

    MDR report key: 11693335 · Received April 20, 2021

    Report

    Report Number
    9616656-2021-00416
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903282036
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 29GA 12.7MM 100 BX 1200 USA WAS NOT WORKING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328203 BATCH NO. 6103598. IT WAS REPORTED THAT NUMBERS WERE LOW AFTER TAKING INJECTION AND IS NOT SURE IF FULL DOSAGE WAS RECEIVED. PR (B)(4) RECORDS ISSUE OF GLUCOSE LEVEL, DIFFICULT/UNABLE TO OPERATE, AND EXPIRATION DATE MISSING FROM SHELF CARTON FOR CAT 328203. VERBATIM: SPOUSE CALLED IN TO GET ASSISTANCE WITH EXPIRATION DATES. STATED, HER HUSBAND HAS BEEN USING PRODUCTS. STATED, HIS NUMBERS WERE LOW AFTER TAKING INJECTION AND SHE IS NOT SURE HE RECEIVED COMPLETE DOSAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 29GA 12.7MM 100 BX 1200 USA WAS NOT WORKING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328203 BATCH NO. 6103598. IT WAS REPORTED THAT NUMBERS WERE LOW AFTER TAKING INJECTION AND IS NOT SURE IF FULL DOSAGE WAS RECEIVED. (B)(4) RECORDS ISSUE OF GLUCOSE LEVEL, DIFFICULT/UNABLE TO OPERATE, AND EXPIRATION DATE MISSING FROM SHELF CARTON FOR CAT 328203. VERBATIM: SPOUSE CALLED IN TO GET ASSISTANCE WITH EXPIRATION DATES. STATED, HER HUSBAND HAS BEEN USING PRODUCTS. STATED, HIS NUMBERS WERE LOW AFTER TAKING INJECTION AND SHE IS NOT SURE HE RECEIVED COMPLETE DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593756 PEN NDL 29GA 12.7MM 100 BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 328203 6103598 00382903282036

    Patients

    Seq Age Sex Outcome Treatment
    1