BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOSHOT SYRINGE

    MDR report key: 15610843 · Received October 14, 2022

    Report

    Report Number
    3002682307-2022-00270
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 22-NOV-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302250 AND LOT NUMBER 2112456. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE SYRINGE BARREL WAS OBSERVED FILLED WITH A CLEAR LIQUID WITH A GREEN PIECE OF MATERIAL FLOATING IN THE LIQUID. SIMULATED FLUSH TESTING WAS PERFORMED ON THE FOREIGN MATERIAL IN AN ATTEMPT TO EXPEL THE FOREIGN MATERIAL FROM THE SYRINGE. THE FIRST ATTEMPT WAS PERFORMED WITH THE PROVIDED SYRINGE SAMPLE; HOWEVER, THE FOREIGN MATERIAL WAS TOO LARGE TO BE EXPELLED. THE SOLOSHOT MINI SYRINGE IS A RE-USE PREVENTION PRODUCT, IN WHICH THE PLUNGER IS LOCKED INSIDE THE BARREL AFTER A SINGLE USE. DUE TO THE SINGLE USE FUNCTIONALITY, THE SYRINGE WAS CUT OPEN AND THE FOREIGN MATERIAL WAS INTRODUCED TO A SIMILAR PRODUCT WITHOUT THE RE-USE PREVENTION FEATURE, A FLU+ SYRINGE, FOR THE REMAINING FLUSH TESTS. THROUGHOUT THE TEN FLUSH TESTS PERFORMED, THE FOREIGN MATTER COULD NOT BE EXPELLED. FOURIER-TRANSFORM INFRARED SPECTROSCOPY WAS THEN PERFORMED AND THE RESULTS SHOWED THAT THE FOREIGN MATERIAL¿S COMPOSITION WAS MOST SIMILAR TO POLYCARBONATE. IT HAS BEEN CONCLUDED THAT THE FOREIGN MATERIAL WAS A PIECE OF A RACK FROM THE ASSEMBLY PROCESS. IN ORDER TO MOVE THE PRODUCT PIECES THROUGH THE ASSEMBLY PROCESS, GREEN PLASTIC RACKS ARE USED. DUE TO FRICTION BETWEEN THE RACKS AND THE MACHINE RAILS, SMALL PLASTIC PARTICLES MAY BE PRODUCED. THE ACCUMULATION OF PARTICLES COULD END UP IN THE SYRINGE PRODUCT DUE TO STATIC ELECTRICITY. ALTHOUGH THE HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, BD KEEPS THE PARTICULATE MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE FOLLOWED. WE ARE CONFIDENT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. THE MANUFACTURING FACILITY PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT IN ORDER TO RAISE FURTHER AWARENESS FOR THIS TYPE OF DEFECT ON THE PRODUCTION FLOOR. IN RESPONSE TO THIS INCIDENT, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN OPENED IN ORDER TO IMPLEMENT ACTIONS TO PREVENT THIS TYPE OF ISSUE FROM OCCURRING. A COMPREHENSIVE PROGRAM HAS BEEN INITIATED, WHICH INCLUDES ALL ASPECTS OF PRODUCTION OPERATIONS, IN ORDER TO ELIMINATE A WIDE RANGE OF POTENTIAL SOURCES OF FOREIGN MATTER.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. 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 · 0

    IT WAS REPORTED THAT THE BD SOLOSHOT SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SOLOSHOT SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629077 BD SOLOSHOT SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown