BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17658851 · Received August 30, 2023

    Report

    Report Number
    1213809-2023-00943
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 13-SEP-2023. H.6. INVESTIGATION SUMMARY: ONE OPENED PACKAGE SAMPLE FROM LOT 3082651 AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED AND 3/8" DARK GREY CLUSTER OF FIBROUS MATERIAL OBSERVED INSIDE THE FLUID PATH. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS DETERMINED THE FIBROUS MATERIAL POSSIBLY A CLEANING PAD USED IN THE MANUFACTURING FACILITY. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU INVESTIGATE THIS ¿ REPORTS OF SOME SORT OF ¿FLUFF¿ OR MOULD LIKE SUBSTANCE IN THIS BATCH OF SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU INVESTIGATE THIS ¿ REPORTS OF SOME SORT OF ¿FLUFF¿ OR MOLD LIKE SUBSTANCE IN THIS BATCH OF SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603279 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3082651 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown