BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    MDR report key: 10782843 · Received November 3, 2020

    Report

    Report Number
    9616656-2020-01092
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 14, 2020
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-12-08. H6: INVESTIGATION SUMMARY: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9303415, CAT. NO.320559 ALONG WITH TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 0022842 AND FIVE PHOTOS. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES FROM LOT. NO. 9303415 AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE TWO SAMPLES. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE TWO OPEN SAMPLES FROM LOT. NO. 0022842 AND A BROKEN NON PATIENT END CANNULA WAS OBSERVED ON ONE SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. DUE TO THE CONDITION THE SAMPLES WERE RECEIVED NO CLOG TESTING COULD BE CARRIED OUT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER (PHARMACY) RECEIVED A PHONE CALL FROM A PATIENT WHO HAS RECENTLY SWITCHED TO MICRO-FINE PRO (320559). THE PATIENT STATED THAT DRUG DIDN'T COME OUT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9303415, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-10-30, MEDICAL DEVICE LOT #: 0022842, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-01-22. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER (PHARMACY) RECEIVED A PHONE CALL FROM A PATIENT WHO HAS RECENTLY SWITCHED TO MICRO-FINE PRO (320559). THE PATIENT STATED THAT DRUG DIDN'T COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247819 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1