BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 100 BX 1200 CA

    MDR report key: 10388838 · Received August 10, 2020

    Report

    Report Number
    9616656-2020-00762
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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. SEE H.10.

    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: 8/17/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) OPEN 4MM, 32G PEN NEEDLE WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE NEEDLE BENT AT NON PATIENT END DURING INJECTION AND THERE WAS A NEEDLE CLOG AND PEN JAMMED UP DURING INJECTION. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING PROPERLY THROUGH THE CANNULA. 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. 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 AN UNSPECIFIED NUMBER OF PEN NDL 32GA 4MM 100 BX 1200 CA WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE BENT AT NON PATIENT END DURING INJECTION. ALSO REPORTED NEEDLE CLOG DURING INJECTION. STATED THAT HE NOTICED THE BENT NEEDLE WHEN HE TRIED TO INJECT AND THE PEN JAMMED DURING INJECTION. LOT #: 0014209 CATALOG #: 320144 DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32GA 4MM 100 BX 1200 CA WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE BENT AT NON PATIENT END DURING INJECTION. ALSO REPORTED NEEDLE CLOG DURING INJECTION. STATED THAT HE NOTICED THE BENT NEEDLE WHEN HE TRIED TO INJECT AND THE PEN JAMMED DURING INJECTION. LOT #: 0014209. CATALOG #: 320144.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32 GA 4 MM 100 BX 1200 CA WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE BENT AT NON PATIENT END DURING INJECTION. ALSO REPORTED NEEDLE CLOG DURING INJECTION. STATED THAT HE NOTICED THE BENT NEEDLE WHEN HE TRIED TO INJECT AND THE PEN JAMMED DURING INJECTION. LOT #: 0014209, CATALOG #: 320144, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853435 PEN NDL 32GA 4MM 100 BX 1200 CA PEN NEEDLE FMI BECTON DICKINSON AND CO. 0014209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other