BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 12436744 · Received September 7, 2021

    Report

    Report Number
    1213809-2021-00615
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. A PARTIALLY OPENED BLISTERPAK FROM BATCH #0213113 (P/N 309646) AND A LOOSE 5ML SYRINGE WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. THE 5ML SYRINGE RECEIVED WITH THE BLISTERPAK WAS AN ORAL SYRINGE WITH AN ORAL PRINTED SCALE. THE SYRINGE DID NOT MATCH THE LUER-LOCK PRODUCT INTENDED TO BE IN THE PACKAGE AND WAS THEREFORE NON-CONFORMING PER PRODUCT SPECIFICATION. SEVERAL ISSUES WERE NOTED WHEN EXAMINING THE RETURN TO LUER-LOCK PRODUCTION RECORDS: - A PRINT CYLINDER CHANGE FROM ORAL TO LUER-LOCK WAS NOT DOCUMENTED ON ONE OF THE MARKING MACHINES. - PRODUCT FLAGGED FOR RETURN WAS NOT PROPERLY NOTED ON THE ASSEMBLY LINE CLEARANCE. - NO PACKAGING LINE CLEARANCE WAS PERFORMED AFTER THE RUN OF ORAL BARRELS THROUGH THE ASSEMBLY MACHINE. - THESE ISSUES WERE NOT DETECTED AT DEVISE HISTORY RECORD REVIEW PRIOR TO ORDER RELEASE. OPERATORS AND TECHNICIANS WERE INTERVIEWED. IT WAS CONFIRMED THAT A LINE CLEARANCE FOR PACKAGING WAS NOT REQUIRED PER PROCEDURE AND THEREFORE WAS NOT PERFORMED. THE MANUFACTURING PROCESS WAS REVIEWED. THE STOP GATE ON THE OVERHEAD ASSEMBLY CONVEYOR THAT DIVERTS PRODUCT FROM PACKAGING IS A PNEUMATICALLY OPERATED SYSTEM. IT WAS ALSO NOTED THAT WITH ENOUGH BACK PRESSURE FROM A CONVEYOR JAM THE GATE CAN POTENTIALLY BE MOVED TO ALLOW PRODUCT TO PASS THROUGH. A PROCESS ENGINEER WAS CONSULTED AND DETERMINED THAT THE SYSTEM WAS NOT OPTIMALLY SET-UP TO DIVERT PRODUCT. THERE WAS ONE INSTANCE OF A RECORDED CONVEYOR JAM DURING BATCH MANUFACTURE. POTENTIAL ROOT CAUSES FOR THE MIXED PRODUCT DEFECT WERE IDENTIFIED AS FOLLOWS: 1) INADEQUATE LINE CLEARANCE PROCEDURE. A. PACKAGING LINE CLEARANCE NOT PERFORMED AFTER PRODUCT CHANGE. 2) INADEQUATE AIR PRESSURE SUPPLY TO THE STOP GATE. A. WEAK AIR SUPPLY TO THE STOP GATE ALLOWED IT TO BE PUSHED OPEN DURING A CONVEYOR JAM. THIS WOULD ALLOW UNINTENDED PRODUCT TO BE INTRODUCED TO THE PACKAGING HOPPER. 3) FAILURE TO CONTAIN THE DEFECT DURING QUALITY REVIEW OF DEVISE HISTORY RECORD. A. INATTENTION TO DETAIL DURING REVIEW. PICKUP ORDERS ARE RUN INFREQUENTLY AND REQUIRE ONLY PARTIAL LINE CLEARANCE PER CURRENT PROCEDURE. THIS SITUATION CAN INCREASE THE CHANCE OF MISTAKES BY THE REVIEWER. THE FOLLOWING CORRECTIVE ACTIONS WERE IDENTIFIED TO ADDRESS THE ROOT CAUSES: 1) LINE CLEARANCE PROCEDURE WILL BE UPDATED TO INCLUDE REQUIREMENT FOR PACKAGING LINE CLEARANCE IN ALL BATCH CHANGE SCENARIOS. DUE 11/30/2021. 2) A FLOW CONTROL WILL BE ADDED TO THE STOP GATE AIR SUPPLY TO ENSURE ENOUGH AIR IS DRIVEN TO THE GATE FOR IDEAL PRODUCT DIVERSION AND JAM PROTECTION. DUE 01/30/2022. 3) PROCEDURE WILL BE UPDATED TO DISALLOW PICKUP ORDERS. DUE 11/30/2021 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD INCORRECT LABEL INFORMATION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE LABEL ON THE BLISTERPACK DOES NOT MATCH WHAT IS SAID ON THE SYRINGE ITSELF.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE LABEL ON THE BLISTERPACK DOES NOT MATCH WHAT IS SAID ON THE SYRINGE ITSELF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330525 BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309646 0213113 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1