BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 5/8IN

    MDR report key: 10962393 · Received December 7, 2020

    Report

    Report Number
    3002682307-2020-00389
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 10, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: 2020-12-28. H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 200109 AND 200409. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FORTY-FOUR PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ALL OF THE RETURNED SAMPLES HAD BEEN SEPARATED FROM THE PACKAGING STRIP AND NO NEEDLES WERE JOINED IN THE BLISTER PACKAGING. THEREFORE, OUR QUALITY TEAM WAS UNABLE TO PERFORM A STRIP TEARING FUNCTIONAL TEST TO CONFIRM THE CUSTOMERS REPORTED ISSUE. HOWEVER, THIRTY-NINE OF THE PACKAGES SHOWED TORN PACKAGING FILM AND PAPER. THE DAMAGED PACKAGING MOST LIKELY RESULTED FROM DEFECTIVE CUTTING OF THE BLISTER PACKAGES DURING PRODUCTION. THE DEFECTIVE CUTTING COULD HAVING RESULTED FROM A MECHANICAL FAILURE OR A MISALIGNMENT. IN ONE PICTURE PROVIDED BY THE CUSTOMER, A BLACK PARTICLE WAS OBSERVED WITHIN THE BLISTER; HOWEVER, NO SIGNS OF FOREIGN MATER WERE OBSERVED WITHIN ANY OF THE RETURNED PHYSICAL SAMPLES. THEREFORE, FURTHER TESTING TO IDENTIFY THE FOREIGN MATTER REPORTED COULD NOT BE COMPLETED. THIS PRODUCT IS ASSEMBLED AND PACKAGED WITHIN AN ENVIRONMENTAL CONTROLLED ROOM WHERE THERE ARE SEVERAL STRICT PREVENTIVE MEASURES IN PLACE TO ENSURE THAT FOREIGN MATTER RISKS ARE KEPT AS LOW AS POSSIBLE. WE BELIEVE THAT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THESE POTENTIAL DEFECTS AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25GA 5/8IN PACKAGE HAD POOR PERFORATION ON 80 OCCASIONS AND FOREIGN MATTER ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1) PCS WITH PACKAGING DAMAGED/BROKEN WHILE SEPARATING THE SINGLE BLISTER FROM THE STRIP DUE TO IMPERFECTIONS OF THE DOTTED SEPARATION LINE; THIS CAN HAVE A NEGATIVE IMPACT ON THE PRODUCT STERILITY. (2) PCS WITH FOREIGN BODIES INSIDE THE BLISTER; THESE DEFECTS ARE CRITICAL, AS THEY HAVE BEEN DETECTED ON STERILE MEDICAL DEVICES THAT HAVE BEEN MARKETED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 200109, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-08. MEDICAL DEVICE LOT #: 200409, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-04-02. 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 NEEDLE 25GA 5/8IN PACKAGE HAD POOR PERFORATION ON 80 OCCASIONS AND FOREIGN MATTER ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1) PCS WITH PACKAGING DAMAGED/BROKEN WHILE SEPARATING THE SINGLE BLISTER FROM THE STRIP DUE TO IMPERFECTIONS OF THE DOTTED SEPARATION LINE; THIS CAN HAVE A NEGATIVE IMPACT ON THE PRODUCT STERILITY. (2) PCS WITH FOREIGN BODIES INSIDE THE BLISTER; THESE DEFECTS ARE CRITICAL, AS THEY HAVE BEEN DETECTED ON STERILE MEDICAL DEVICES THAT HAVE BEEN MARKETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428804 NEEDLE 25GA 5/8IN NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1