BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER

    MDR report key: 8755817 · Received July 2, 2019

    Report

    Report Number
    2618282-2019-00214
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903649025
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 8200984. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-08-29.

    Description of Event or Problem · 0

    MATERIAL NO: 364902 . BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER THE ITEM WAS LEAKING AT THE INCISION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I UNDERSTAND ITEM 364902 HAS BEEN DISCONTINUED AND NO LONGER IN USE, HOWEVER I HAVE A COMPLAINT REGARDING THE ITEM LEAKING AT THE INCISION SITE.

    Description of Event or Problem · 0

    MATERIAL NO: 364902, BATCH NO: 8200984. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER THE ITEM WAS LEAKING AT THE INCISION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I UNDERSTAND ITEM 364902 HAS BEEN DISCONTINUED AND NO LONGER IN USE, HOWEVER I HAVE A COMPLAINT REGARDING THE ITEM LEAKING AT THE INCISION SITE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO: 364902. BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER THE ITEM WAS LEAKING AT THE INCISION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I UNDERSTAND ITEM 364902 HAS BEEN DISCONTINUED AND NO LONGER IN USE, HOWEVER I HAVE A COMPLAINT REGARDING THE ITEM LEAKING AT THE INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547088 BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 8200984 50382903649025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other