BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SOLOSHOT IX 1ML 22GA 1IN

    MDR report key: 11904986 · Received May 28, 2021

    Report

    Report Number
    3002682307-2021-00219
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1910002. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ONE PICTURE SHOWED A PALLET OF SOLOSHOT IX SHIPPING BOXES (TERTIARY PACKAGING) IN WHICH BLISTER PACKAGES OF NEEDLE PRODUCT BELONGING TO LOT 190919 WERE OBSERVED LOOSE ABOVE THE SHIPPING BOX. THE PALLET SHIPPING BOXES ARE SHOWN ON A PLASTIC PALLET, WHICH IS NOT USED WITHIN THE MANUFACTURING PLANT. ANOTHER PICTURE SHOWS A SOLOSHOT IX SHELF CARTON (SECONDARY PACKAGING) IN WHICH TWO OF THE BLISTER PACKAGING STRIPS ARE SHOWN IN THE SAME POSITION AT THE TOP OF THE OPENED CARTON. A REVIEW OF THE PRODUCTION HISTORY FOR BOTH THE SOLOSHOT LOT NUMBER AND THE MICROLANCE NEEDLE LOT NUMBER DID NOT REVEAL ANY REPROCESSING OR SEGREGATION ISSUES. EACH OF THESE PRODUCT LOT NUMBERS WERE MANUFACTURED ON SEPARATE DAYS, WITH OVER TWO WEEKS OF SEPARATION. BASED ON THE INVESTIGATIVE FINDINGS, IT HAS BEEN DETERMINED THAT THESE PRODUCTS DID NOT COINCIDE AT ANY STEP OF THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE SOLOSHOT IX 1ML 22GA 1IN HAD A MIX OF PRODUCT TYPES IN THE PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 7 NEEDLE STRIPS FROM A DIFFERENT ITEM THESE WERE FOUND LOOSE IN BETWEEN STACKED CB'S ON THE PALLET".

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1910002. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ONE PICTURE SHOWED A PALLET OF SOLOSHOT IX SHIPPING BOXES (TERTIARY PACKAGING) IN WHICH BLISTER PACKAGES OF NEEDLE PRODUCT BELONGING TO LOT 190919 WERE OBSERVED LOOSE ABOVE THE SHIPPING BOX. THE PALLET SHIPPING BOXES ARE SHOWN ON A PLASTIC PALLET, WHICH IS NOT USED WITHIN THE MANUFACTURING PLANT. ANOTHER PICTURE SHOWS A SOLOSHOT IX SHELF CARTON (SECONDARY PACKAGING) IN WHICH TWO OF THE BLISTER PACKAGING STRIPS ARE SHOWN IN THE SAME POSITION AT THE TOP OF THE OPENED CARTON. A REVIEW OF THE PRODUCTION HISTORY FOR BOTH THE SOLOSHOT LOT NUMBER AND THE MICROLANCE NEEDLE LOT NUMBER DID NOT REVEAL ANY REPROCESSING OR SEGREGATION ISSUES. EACH OF THESE PRODUCT LOT NUMBERS WERE MANUFACTURED ON SEPARATE DAYS, WITH OVER TWO WEEKS OF SEPARATION. BASED ON THE INVESTIGATIVE FINDINGS, IT HAS BEEN DETERMINED THAT THESE PRODUCTS DID NOT COINCIDE AT ANY STEP OF THE MANUFACTURING PROCESS. TAKING ALL FINDINGS INTO CONSIDERATION, IT IS MOST LIKELY THAT THIS ISSUE RESULTED FROM MANIPULATION OF THE PRODUCT DURING STORAGE, POST-PRODUCTION. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED WITHIN THE MANUFACTURING FACILITY TO FURTHER REVIEW THIS REPORTED ISSUE AND PREVENT ANY RISKS OF POSSIBLE RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE SOLOSHOT IX 1ML 22GA 1IN HAD A MIX OF PRODUCT TYPES IN THE PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 7 NEEDLE STRIPS FROM A DIFFERENT ITEM THESE WERE FOUND LOOSE IN BETWEEN STACKED CB'S ON THE PALLET. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799109 SYRINGE SOLOSHOT IX 1ML 22GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1910002

    Patients

    Seq Age Sex Outcome Treatment
    1