BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® CONTACT-ACTIVATED LANCET

    MDR report key: 18990432 · Received March 28, 2024

    Report

    Report Number
    2243072-2024-00453
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMK
    UDI-DI
    30382903665939
    PMA / PMN Number
    K223243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: D4A49B7. D4. MEDICAL DEVICE EXPIRATION DATE: 15-02-2028. H4. DEVICE MANUFACTURE DATE: 13-06-2023. E.1 INITIAL REPORTER CITY: KAISEI TOWN, ASHIGARAKAMI DISTRICT. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D.9:DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 2024-APRIL- 5TH H.6 INVESTIGATION SUMMARY MATERIAL #: 366593 LOT/BATCH #: C4P61M4 & D4A49B7 BD RECEIVED 200 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE FOLLOWING DEFECTS WERE OBSERVED: FROM LOT NUMBER C4P61M4 THERE WERE 4 LANCETS WITH DISCOLORED HOUSING, 1 LANCET WITH CRACKED HOUSING, 4 LANCETS WITH MOLDING DEFECTS ON THEIR HOUSING, 2 LANCETS WITH HOUSING SEPARATION, AND 6 LANCETS WITH FOREIGN MATTER. FROM LOT NUMBER D4A49B7 THERE WERE 2 LANCETS WITH DISCOLORED HOUSING, 2 LANCETS WITH HOUSING SEPARATION, AND 7 LANCETS WITH FOREIGN MATTER. ADDITIONALLY, RETENTION SAMPLES OF EACH REPORTED LOT NUMBER FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND UPON COMPLETION NO DEFECTS OR FAILURES WERE OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES DISCOLORED HOUSING, CRACKED HOUSING, MOLDING DEFECT, HOUSING SEPARATION, AND FOREIGN MATTER. THE INDICATED FAILURE MODES WERE ATTRIBUTED TO THE SUPPLIER. THE SUPPLIER HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUES OF FOREIGN MATTER, CRACKED HOUSING, HOUSING SEPARATION, MOLDING DEFECTS, AND CRACKED SHIELD THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT MULTIPLE DEFECTS WERE IDENTIFIED. THE CUSTOMER DISCOVERED LANCETS WITH FOREIGN MATTER, ASSEMBLY DEFECTS, MOLDING DEFECTS, CRACKS, AND DISCOLORATION. THE DEFECTS WERE DISCOVERED PRIOR TO USE, AND NO IMPACT TO PATIENTS WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT MULTIPLE DEFECTS WERE IDENTIFIED. THE CUSTOMER DISCOVERED LANCETS WITH FOREIGN MATTER, ASSEMBLY DEFECTS, MOLDING DEFECTS, CRACKS, AND DISCOLORATION. THE DEFECTS WERE DISCOVERED PRIOR TO USE, AND NO IMPACT TO PATIENTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911038 BD MICROTAINER® CONTACT-ACTIVATED LANCET MANUAL SURGICAL INSTRUMENT FOR GENERAL USE FMK BECTON DICKINSON C4P61M4 30382903665939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown