BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 9672106 · Received February 5, 2020

    Report

    Report Number
    1213809-2020-00059
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    November 13, 2019
    Report Date
    March 5, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903097036
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBERS 9227666 & 9080635 AND ALL APPLICABLE SUB-ASSEMBLY PRODUCT LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS A SAMPLE WAS UNAVAILABLE FOR THIS SPECIFIC INCIDENT AND COMPLAINT RECORD, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE INVESTIGATION. AT THIS TIME, A MANUFACTURING RELATED CAUSE FOR THIS REPORTED INCIDENT CANNOT BE DETERMINED. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ALL REPORTED INCIDENTS WILL BE CLOSELY REVIEWED FOR TRACKING AND TRENDING PURPOSES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED PAST THE STOPPER DURING USE. LOT#'S 9227666 AND 9080635 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 11TH OF 14 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE NUMBER OF LEAKING SYRINGES LEADING TO HIGH REJECT RATES IN FINISHED PRODUCT. LEAKING SYRINGES IDENTIFIED DURING VISUAL INSPECTION OF FINISHED PRODUCT." "THESE LOTS WERE LEAKING PAST THE STOPPER."

    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 #: 9227666. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 9080635. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2019-04-18. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED PAST THE STOPPER DURING USE. LOT#'S 9227666 AND 9080635 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 11TH OF 14 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE NUMBER OF LEAKING SYRINGES LEADING TO HIGH REJECT RATES IN FINISHED PRODUCT. LEAKING SYRINGES IDENTIFIED DURING VISUAL INSPECTION OF FINISHED PRODUCT." "THESE LOTS WERE LEAKING PAST THE STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137956 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 00382903097036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other