BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31X8 FRANCE 100BX

    MDR report key: 8655482 · Received May 30, 2019

    Report

    Report Number
    9616656-2019-00492
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 10, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FOUR OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8171677, CAT. NO. 325108. VISUAL EXAMINATION WAS CARRIED A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ALL FOUR SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TESTING COULD BE CARRIED OUT. 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 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.

    Additional Manufacturer Narrative · 0

    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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 31X8 FRANCE 100BX EXPERIENCED A FAILURE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE PATIENT BROUGHT BACK A BOX OF BD PRODUCTS BECAUSE SHE FOUND SOME WITH CLOGS. REF : 325108. LOT : 8171677. EXPIRY DATE : 2023-06.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 31X8 FRANCE 100BX EXPERIENCED A FAILURE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE PATIENT BROUGHT BACK A BOX OF BD PRODUCTS BECAUSE SHE FOUND SOME WITH CLOGS. REF : 325108. LOT : 8171677. EXPIRY DATE : 2023-06.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 31X8 (B)(6) 100BX EXPERIENCED A FAILURE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE PATIENT BROUGHT BACK A BOX OF BD PRODUCTS BECAUSE SHE FOUND SOME WITH CLOGS. REF : 325108, LOT : 8171677, EXPIRY DATE : 2023-06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447209 PN 31X8 FRANCE 100BX PEN NEEDLE FMI BECTON DICKINSON AND CO. 8171677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other