BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB

    MDR report key: 10022774 · Received May 4, 2020

    Report

    Report Number
    1213809-2020-00286
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059059
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: (B)(6) 2020 H.6. INVESTIGATION SUMMARY THREE PHOTOS AND ONE LOOSE 3ML SYRINGE AND SAFETYGLIDE NEEDLE ASSEMBLY WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LENGTHWISE CRACK IN HUB STARTING AT THE TOP AND EXTENDING DOWN INTO THE ASSEMBLY. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE PLASTIC HUB MOLDING. DURING THE MOLDING PROCESS A SHORT SHOT HAPPENED INDUCING THE DEFECT SHOWN IN THE PHOTO. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9214058 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT 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.6. INVESTIGATION: THREE PHOTOS OF A LOOSE 3ML SYRINGE AND SAFETYGLIDE NEEDLE ASSEMBLY WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LENGTHWISE CRACK IN HUB STARTING AT THE TOP AND EXTENDING DOWN INTO THE ASSEMBLY. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CRACKED HUB DEFECT IS ASSOCIATED WITH THE PLASTIC HUB MOLDING. DURING THE MOLDING PROCESS A SHORT SHOT HAPPENED INDUCING THE DEFECT SHOWN IN THE PHOTO. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9214058 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB HUB WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB DEFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB HUB WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB DEFORMED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB HUB WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483740 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305905 9214058 30382903059059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other