BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML W/O

    MDR report key: 8426712 · Received March 16, 2019

    Report

    Report Number
    2243072-2019-00500
    Event Type
    Malfunction
    Date Received
    March 16, 2019
    Date of Event
    February 28, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1810224. VISUAL INSPECTION OF COMPLAINT SAMPLE: SBDM VISUALLY INSPECTED THE COMPLAINT SAMPLE AND NOTICED FM IN THE BARREL. INFRARED SPECTROMETRY (IR) ANALYSIS: SBDM CONDUCTED IR ANALYSIS ON THE FM, RESULTS WERE THE FM WAS FOUND TO BE THE SAME AS RAW MATERIAL OF BARREL, POLYPROPYLENE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30PCS EACH FROM 3 LOTS (1810013, 1810224 AND 1812062), NO ABNORMALITY WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1810224, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL CUSTOMER COMPLAINT RECORD, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE MANUFACTURING PROCESS WORKERS AND QUALITY INSPECTORS. 2. SBDM WILL CONDUCT INTENSIVE MAINTENANCE & CLEANING FOR 50ML SYRINGE BARREL INJECTION MOLD. 3. SBDM WILL CONTINUE TO MONITOR SYRINGE MANUFACTURING PROCESS TO SEE IF THE SAME COMPLAINT CASE OCCURS AGAIN. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. FROM IR ANALYSIS, THE FM IS DETERMINED TO BE PP, SAME MATERIAL AS BARREL. FROM INVESTIGATION, THE 50ML SYRINGE BARREL COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (220~240). THE LIKELY CAUSE IS THAT PP (POLYPROPYLENE, RAW MATERIAL OF 50ML SYRINGE BARREL) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR GAS EMISSION LINE ON THE MOLD WAS BLOCKED TEMPORARY AND THE GAS FORMED CARBIDE. SUBSEQUENTLY IT WAS STUCK INTO THE COMPLAINT 50ML SYRINGE BARREL DURING INJECTION PROCESS. SBDM HAS IN HOUSE CAPA-19-013 IN PLACE TO MONITOR DEFECT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML W/O EXPERIENCED FOREIGN MATTER CONTAMINATION. THE CUSTOMER STATED, ¿THERE IS FOREIGN MATERIAL IN THE 50ML SYRINGE ((B)(4)). THE FLUID IN THE SYRINGE IS NS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 50ML W/O EXPERIENCED FOREIGN MATTER CONTAMINATION. THE CUSTOMER STATED, ¿THERE IS FOREIGN MATERIAL IN THE 50ML SYRINGE (59008488). THE FLUID IN THE SYRINGE IS NS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219876 SYRINGE 50ML W/O SYRINGE FMF BECTON DICKINSON 1810224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other