BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10047826 · Received May 12, 2020

    Report

    Report Number
    1213809-2020-00299
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 21, 2020
    Report Date
    May 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE 10ML SYRINGE IN A OPENED BLISTER PACK FROM BATCH 0043427 (P/N 302995) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LARGER FOREIGN MATTER FIBER PRESENT INSIDE THE PACKAGE AND A SMALLER FIBER PRESENT IN THE SYRINGE, OUTSIDE THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A BUILD UP OF TOP WEB AND WAS LARGER THAN LEVEL 3 IN SIZE WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THERE IS A FRICTION POINT WITH THE TOP WEB OVER THAT CAUSES A BUILD-UP OF FIBER-LIKE WEB MATERIAL. THE BUILD-UP OCCURRED OVER EXPOSED PACKAGES WITH NO BARRIER IN BETWEEN. A NEW COVER WAS INSTALLED TO CONTAIN THE BUILD UP OF FOREIGN MATTER AS OF 4/21/2020. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0043427. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0043427 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FOREIGN "SHAVING OR OBJECT" WAS FOUND IN THE SEALED BD SYRINGE LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHORT DESCRIPTION: OBJECT IN SEALED SYRINGE DETAILED INCIDENT DESCRIPTION: SHAVING OR OBJECT INSIDE SEALED SYRINGE".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A FOREIGN "SHAVING OR OBJECT" WAS FOUND IN THE SEALED BD SYRINGE LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHORT DESCRIPTION: OBJECT IN SEALED SYRINGE DETAILED INCIDENT DESCRIPTION: SHAVING OR OBJECT INSIDE SEALED SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509916 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0043427 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other