BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE

    MDR report key: 6879385 · Received September 20, 2017

    Report

    Report Number
    1213809-2017-00129
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 28, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7122747, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-05-02. MEDICAL DEVICE LOT #: 7002832, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2017-01-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI#:(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW FOR BATCH 7122747 (P/N 301027): MANUFACTURING DATES: 5/25/17 - 5/27/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7122747 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7002832 (P/N 301027): MANUFACTURING DATES: 1/17/17 TO 1/20/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. DURING A VISUAL INSPECTION BROKEN PLUNGER RODS WERE FOUND. THE PROCESS WAS STOPPED AND PRODUCT REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 7002832 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: FOUR LOOSE 5ML ASSEMBLED SYRINGES WERE RECEIVED BY BD (B)(4) AND VISUALLY EVALUATED. BATCH #7122747 ¿ 2 ASSEMBLED 5ML SYRINGES - BOTH SAMPLES HAD BLACK FOREIGN MATTER SPOTS THE ENTIRE LENGTH OF PRINTED BARREL, SOME LARGER THAN LEVEL 3 IN SIZE. THE FM APPEARS TO BE INK SPLATTER FROM THE PRINTING PROCESS. THIS SIZE OF FM IS A REJECTABLE CONDITION PER CANAAN¿S INTERNAL PRINT STANDARD. BATCH #7002832 - 2 ASSEMBLED 5ML SYRINGES - BOTH SAMPLES HAD DISTORTED STOPPERS WHICH IS A REJECTABLE CONDITION AT BD CANAAN. THE DEFECT LIKELY OCCURRED IN THE ASSEMBLY PROCESS. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER (¿INK STAIN¿) WAS FOUND IN BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE(S), AS WELL AS DEFECTIVE PLUNGERS, BEFORE USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658516 BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other