BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML SYRINGE LUER-LOCK¿ TIP BULK STERILE CONVENIENCE PAK

    MDR report key: 7060563 · Received November 27, 2017

    Report

    Report Number
    9610847-2017-00144
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 23, 2017
    Report Date
    February 23, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNABLE TO CONFIRM THE FAILURE MODE SINCE NO PICTURES OR SAMPLES WERE RECEIVED (ILLEGIBLE PRINT/MARKINGS ON SYRINGE BARRELS). HOWEVER, DUE TO THE DEFECT DESCRIPTION, THIS PROBLEM WAS LIKELY CAUSED IN THE PRINTING PROCESS OF THE SUPPLIER FACILITY. IF SAMPLES RECEIVED, ANOTHER INVESTIGATION WILL BE OPEN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #7152900.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: TEN UNITS WERE RECEIVED FOR EVALUATION. EACH UNIT WAS VISUALLY INSPECTED AND THE REPORTED ISSUE WAS CONFIRMED. THIS INCIDENT IS MANUFACTURING RELATED. INVESTIGATION: 10 SAMPLES RECEIVED WITH MINOR MISSING PRINT. NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 7152900 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 7152900 CATALOG #: 305617 QUANTITY PRODUCED: (B)(4). 20ML SYRINGE LOTS (P/N 31884) USED ARE 7052906 & 7052908 FOR LOT 7152900. NO QNS WERE FOUND FOR SYRINGE LOTS 7052906 & 7052908 IN SAP AND INCOMING INSPECTION RECORDS. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED BEFORE AND AFTER PACKAGING THE PRODUCT IN DISPENSERS LOOKING FOR ILLEGIBLE PRINT/MARKINGS ON THE SYRINGES. DURING THE 100% INSPECTION, A VERY SMALL PERCENTAGE OF SYRINGES (0.22%) WITH ILLEGIBLE PRINT/MARKINGS WERE DETECTED AND SCRAPPED BY OUR OPERATORS. ROOT CAUSE: POTENTIALLY CAUSED BY BARREL JAM CREATING A RUB MARK. IT WAS DETERMINED THAT NO CAPA IS REQUIRED. MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ILLEGIBLE PRINT/MARKINGS WERE FOUND ON THE SYRINGE BARREL OF A BD 20ML SYRINGE LUER-LOCK" TIP BULK STERILE CONVENIENCE PAK PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841098 BD 20ML SYRINGE LUER-LOCK¿ TIP BULK STERILE CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152900 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other