BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9791590 · Received March 5, 2020

    Report

    Report Number
    1213809-2020-00163
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: FIVE PHOTOS AND THREE LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED WHAT APPEARED TO BE THREE LOOSE 10ML SYRINGES ¿ THE SAME THAT WERE RECEIVED. ONE SYRINGE HAD A JAMMED STOPPER CONDITION. TWO SYRINGES WERE OBSERVED TO HAVE CRACKED BARRELS EXTENDING LENGTHWISE ALONG THE WALL OUTSIDE THE SCALE MARKINGS. IT WAS UNKNOWN WHICH BATCH # THE SAMPLES BELONGED TO. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER AND CRACKED BARREL DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 8171755 & 8193905 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 BD 10ML SYRINGE LUER-LOK¿ TIP HAD A CRACK IN IT AND THE STOPPER WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS THAT THE THERE IS A CRACK IN SYRINGE AND RUBBER STOPPER IS DEFORMED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8171755. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-20. MEDICAL DEVICE LOT #: 8193905. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-07-12. 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 10ML SYRINGE LUER-LOK¿ TIP HAD A CRACK IN IT AND THE STOPPER WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS THAT THE THERE IS A CRACK IN SYRINGE AND RUBBER STOPPER IS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258888 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other