BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATH TIP BNS

    MDR report key: 8169980 · Received December 17, 2018

    Report

    Report Number
    1911916-2018-00755
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    October 8, 2018
    Report Date
    February 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. IT SHOWS SIX SYRINGES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. THIS IS THE 1ST COMPLAINT FOR THE LOT #7262543 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #7262543 DURING THIS PRODUCTION RUN. INVESTIGATION CONCLUSION: THE SAMPLES SHOW PRINTING INCONSISTENCIES; HOWEVER THOSE ARE ACCEPTABLE. MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. ROOT CAUSE DESCRIPTION: THE CAUSE OF THE PRINTING ISSUES WAS LIKELY A VARIATION IN THE SCALE PRINTING PROCESS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE PRINTING ON THE SYRINGE CATH TIP BNS WAS ILLEGIBLE.

    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 #: 7262543, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2017-09-19. MEDICAL DEVICE LOT #: 8051977, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-02-20. (B)(6). 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 SCALE PRINTING ON THE SYRINGE CATH TIP BNS WAS ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009192 SYRINGE CATH TIP BNS IRRIGATING SYRINGE KYZ BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other