BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD SYRINGE

    MDR report key: 7125932 · Received December 18, 2017

    Report

    Report Number
    1213809-2017-00350
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 23, 2017
    Report Date
    March 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: FIFTEEN SEALED AND TWO OPENED 5ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7191786 (P/N 309649). BASED ON THE VISUAL EVALUATION OF THE RETURNED SAMPLES, NO DEFECTS WERE OBSERVED IN THE FIFTEEN SEALED SYRINGES. TWO OPENED SYRINGES WERE IN SEPARATE SAMPLE BAGS. BOTH SYRINGES HAD A LINEAR CRACK EXTENDING FROM APPROXIMATELY THE 1ML TO THE 4 ML GRAD LINE OPPOSITE THE PRINT AREA. IN BOTH CASES THERE WAS AN IMPACT POINT NEAR THE START OF EACH CRACK LOCATED OPPOSITE THE 1ML GRAD LINE. A CRACKED BARREL IS A REJECTABLE CONDITION AS PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR BATCH 7191786 (P/N 309649) WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7191786 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON SAMPLES, THE INVESTIGATION CONCLUDED NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD BE DETERMINED. BASED ON THE SEVERITY AND OCCURRENCE A CAPA IS NOT NECESSARY. 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO POTENTIAL LOT NUMBERS WERE INVOLVED WITH THIS INCIDENT: MEDICAL DEVICE LOT # = 7191786. MEDICAL DEVICE EXPIRATION DATE = 6/30/2022. DEVICE MANUFACTURE DATE = 7/10/2017. MEDICAL DEVICE LOT # = UNKNOWN. MEDICAL DEVICE EXPIRATION DATE = UNKNOWN. DEVICE MANUFACTURE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, AN UNKNOWN BD SYRINGE WAS ¿LIGHTLY TAPPED WITH A TWEEZER TO VENT¿ CAUSING A CRACK IN THE SYRINGE AND LEAKAGE OF MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905588 UNKNOWN BD SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other