BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK SYRINGE

    MDR report key: 9521545 · Received December 26, 2019

    Report

    Report Number
    9614033-2019-00300
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 22, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9051839, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-04-29. MEDICAL DEVICE LOT #: 8344731, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-02-18. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FIFTEEN SAMPLES RECEIVED FOR INVESTIGATION, THE SAMPLES ARE OPENED AND COULD NOT BE EVALUATED FOR THE REPORTED DEFECT, HOWEVER TEN RETENTION SAMPLES WERE EVALUATED FOR PACKAGE TEARING AND FIBER TEAR IN THE PACKAGE. NO DEFECTS OBSERVED. DHR WAS COMPLETED WITH NO IRREGULARITIES. THE PARAMETERS FOR THE FAILURE MODE REPORTED BY THE CUSTOMER (PRESSURE, TEMPERATURE AND SEALING TIME) WERE WITHIN THE VALIDATED OPERATION WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER LOK¿ SYRINGE PACKAGING WAS DIFFICULT TO OPEN PROPERLY DURING USE, RESULTING IN TORN SHARDS OF PACKAGING PAPER ENTERING THE STERILE OPERATING ROOM. LOT # 9051839 HAD 16 OCCURRENCES OF THIS EVENT, WHILE LOT # 8344731 HAD 1 OCCURRENCE; HOWEVER, THE DATES OF THESE OCCURRENCES ARE UNKNOWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGE IS DIFFICULT TO OPEN PROPERLY. THIS IS AN ONGOING ISSUE. PACKAGE IS DIFFICULT TO OPEN AND TEARING RESULTS IN POTENTIAL COMPROMISE OF STERILE FIELD IN OPERATING ROOM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER LOK¿ SYRINGE PACKAGING WAS DIFFICULT TO OPEN PROPERLY DURING USE, RESULTING IN TORN SHARDS OF PACKAGING PAPER ENTERING THE STERILE OPERATING ROOM. LOT # 9051839 HAD 16 OCCURRENCES OF THIS EVENT, WHILE LOT # 8344731 HAD 1 OCCURRENCE; HOWEVER, THE DATES OF THESE OCCURRENCES ARE UNKNOWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGE IS DIFFICULT TO OPEN PROPERLY. THIS IS AN ONGOING ISSUE. PACKAGE IS DIFFICULT TO OPEN AND TEARING RESULTS IN POTENTIAL COMPROMISE OF STERILE FIELD IN OPERATING ROOM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317002 BD LUER LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other