BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 10785716 · Received November 4, 2020

    Report

    Report Number
    9616656-2020-01097
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/23/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (19) OPEN 4MM, 32G PEN NEEDLES FROM LOT #9317875. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 12 OUT OF 19 SAMPLES EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. FIVE OUT OF 19 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA. BOTH OF THESE ISSUES COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA PROPERLY. BOTH REMAINING PEN NEEDLES WERE TESTED AND BOTH WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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. ROOT CAUSE- USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX 1200 US WAS CLOGGED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320550 BATCH NO:9317875, UNKNOWN (REPORTED 9181444), UNKNOWN (REPORTED 8261658). IT WAS REPORTED THAT THE NEEDLES CLOGGED WITH SOME OF THE PEN NEEDLES FROM DIFFERENT BOXES. VERBATIM: CONSUMER REPORTED NEEDLE CLOG WITH SOME PEN NEEDLES FROM DIFFERENT BOXES. STATED SOMETIMES DURING HIS INJECTIONS THE NEEDLES WILL NOT RELEASE ANY MEDICATION. STATED SOMETIMES THE PEN NEEDLES RELEASE 6 UNITS OF MEDICATION AND THEN STOP. STATED HE THEN HAS TO USE A 2ND NEEDLE TO COMPLETE HIS FULL INJECTION. STATED THIS HAS HAPPENED WITH DIFFERENT LOT #'S.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 9181444 AND 8261658. THESE DO NOT MATCH THE CATALOG NUMBER PROVIDED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9317875, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-11-13, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 HP 100 BOX 1200 US WAS CLOGGED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320550 BATCH NO:9317875, UNKNOWN (REPORTED 9181444), UNKNOWN (REPORTED 8261658). IT WAS REPORTED THAT THE NEEDLES CLOGGED WITH SOME OF THE PEN NEEDLES FROM DIFFERENT BOXES. VERBATIM: CONSUMER REPORTED NEEDLE CLOG WITH SOME PEN NEEDLES FROM DIFFERENT BOXES. STATED SOMETIMES DURING HIS INJECTIONS THE NEEDLES WILL NOT RELEASE ANY MEDICATION. STATED SOMETIMES THE PEN NEEDLES RELEASE 6 UNITS OF MEDICATION AND THEN STOP. STATED HE THEN HAS TO USE A 2ND NEEDLE TO COMPLETE HIS FULL INJECTION. STATED THIS HAS HAPPENED WITH DIFFERENT LOT #'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254223 PEN NDL 32G 4MM HP 100 BOX 1200 US PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1