BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 11874192 · Received May 25, 2021

    Report

    Report Number
    1213809-2021-00369
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: 2021-05-03. H6: INVESTIGATION SUMMARY THIRTY-EIGHT 5ML SYRINGE IN SEALED PACKAGE, CONFIRMED TO BE FROM BATCH #1022874 (P/N 309646), WERE RECEIVED. THE SAMPLES WERE TESTED FOR LEAKAGE PAST STOPPER PER PROCEDURE. 37 SAMPLES PASSED THE TEST WITH NO LEAKAGE OBSERVED. 1 SAMPLE WAS OBSERVED TO HAVE LEAKAGE PAST FRONT RIB ONLY. THE SAMPLE WAS VISUALLY EVALUATED. A SLIGHT UNEVEN EDGE OF THE FIRST RIB WAS OBSERVED. HOWEVER, IT WAS NOT CLEAR IF THAT COULD CONTRIBUTE TO THE LEAKAGE DEFECT. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT COULD NOT BE DETERMINED. IT IS POSSIBLE THE UNEVEN EDGE CONTRIBUTED TO THE LEAKAGE PAST THE FIRST RIB. HOWEVER, NO DAMAGE OR OBVIOUS MOLDING DEFECTS WERE FOUND DURING EVALUATION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 1022874 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309646 BATCH NO.: 1022874 LEAKING, STOPPER NOT SEALED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 THE 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309646, BATCH NO.: 1022874. LEAKING, STOPPER NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777070 5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1022874

    Patients

    Seq Age Sex Outcome Treatment
    1