BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12193635 · Received July 19, 2021

    Report

    Report Number
    1213809-2021-00496
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    May 31, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-20. H6: INVESTIGATION SUMMARY FOUR PHOTOS, ONE LOOSE 10ML SYRINGE (P/N 302995), AND TWO 10ML SYRINGES SEALED IN BLISTERPAKS FROM BATCH #1082949 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. THE TWO SEALED SAMPLES HAD NO VISIBLE DEFECTS PRESENT AND WERE ACCEPTABLE PER PRODUCT SPECIFICATION. A LARGE CRACK EXTENDING FROM THE 2ML GRAD LINE TO JUST BEYOND THE 10ML GRAD LINE WAS PRESENT OUTSIDE OF THE PRINT AREA. THERE ALSO APPEARED TO BE REMNANTS OF A CUSTOMER APPLIED LABEL IN THE SAME AREA AS THE CRACK. THE SYRINGE WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1082949 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP SYRINGE BARRELS WERE CRACKED AND LEAKED MEDICATION DURING THE IV SITE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON THE WEEKEND, ICU USED A SYRINGE THAT WAS SPLIT UP THE SIDE. THE STAFF WERE USING THE SYRINGE TO DRAW UP MEDICATIONS FOR RAPID SEQUENCE INTUBATION. WHEN INJECTING MEDICATION INTO THE PATIENT¿S IV SITE, THE MEDICATION SHOT OUT A SIDE OF THE SPLIT BARREL OF THE SYRINGE. DUE TO THE MALFUNCTION OF THE SYRINGE, TREATMENT WAS DELAYED AS THE STAFF NEEDED TO DEBIT NEW MEDICATION AND THEN DRAW IT UP INTO A SYRINGE FOR ADMINISTRATION."

    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 3 BD LUER-LOK¿ TIP SYRINGE BARRELS WERE CRACKED AND LEAKED MEDICATION DURING THE IV SITE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON THE WEEKEND, ICU USED A SYRINGE THAT WAS SPLIT UP THE SIDE. THE STAFF WERE USING THE SYRINGE TO DRAW UP MEDICATIONS FOR RAPID SEQUENCE INTUBATION. WHEN INJECTING MEDICATION INTO THE PATIENT¿S IV SITE, THE MEDICATION SHOT OUT A SIDE OF THE SPLIT BARREL OF THE SYRINGE. DUE TO THE MALFUNCTION OF THE SYRINGE, TREATMENT WAS DELAYED AS THE STAFF NEEDED TO DEBIT NEW MEDICATION AND THEN DRAW IT UP INTO A SYRINGE FOR ADMINISTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086740 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 1082949 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1