BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 10193046 · Received June 24, 2020

    Report

    Report Number
    3002682307-2020-00198
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901166 AND 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, THREE PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A HAIR WAS OBSERVED WITHIN THE BLISTER PACKAGING. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM AN OPERATOR FAILURE IN PERFORMING GOOD MANUFACTURING PRACTICES. THERE ARE SEVERAL QUALITY CONTROLS IN PLACE TO PREVENT AND DETECT THIS TYPE OF DEFECT AND WE BELIEVE THAT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. A HAIR INSIDE THE BLISTER WAS DETECTED IN THIS PROVIDED PICTURE OF THE AFFECTED SAMPLE. WE COULD CONFIRM THE REPORTED ISSUE. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2020 (B)(6) 2019. SYRINGES WERE ASSEMBLED IN MACHINE Nº4255, Nº4254, Nº4237, Nº4236, Nº4210 AND Nº4220, IN LOT #9014981 (B)(6) 2019. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #9015594, #8353860, RESEARCH HAS FOUND 1 QN (#(B)(4)) RELATED WITH EMBEDDED CONTAMINATION. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #9015598, #8353896, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER ANALYZING THE PICTURE AND THE AFFECTED SAMPLE PROVIDED TO THE MANUFACTURING SITE FOR EVALUATION, WE COULD SEE THE REPORTED FOREIGN MATTER AND CONFIRM THE REPORTED ISSUE. THE HAIR WAS LOST PROBABLY DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, OR NEGLECT, OR AS PART OF SOME RAW MATERIALS. FINALLY, THIS FOREIGN MATTER ENDED IN THE PRIMARY PACKAGING MACHINE WHICH PRODUCED THE MENTIONED NON-CONFORMANCE. DESPITE THE FACT THAT ANY HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. WE CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE. ROOT CAUSE DESCRIPTION: THE HAIR WAS LOST BY THE OPERATOR DURING THE PRIMARY PACKAGING PROCESS AND FINALLY ENDED INSIDE THE BLISTER. RATIONALE: WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO ACTIONS ARE REQUIRED. A REVIEW OF THE P-EURA (B)(4) (¿PACKAGING PEURA STERILE PRODUCT FRAGA¿) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE FMEA DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAIR WAS FOUND IN THE BD¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE DEPARTMENT OPENED FOR USING, HAIR WAS FOUND SEALED IN THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652826 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other