BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 8453684 · Received March 26, 2019

    Report

    Report Number
    1917413-2019-01051
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 30, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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 OVERFILL 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-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OVERFILL 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. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ARE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 363080 BATCH NO. 9002613 IT WAS REPORTED THAT THE TUBES ARE OVERFILLING. 1ST INCIDENT: 04-MARCH COMPLAINT ID (B)(4), 2ND INCIDENT: 05-MARCH COMPLAINT ID (B)(4), 3RD INCIDENT: 06-MARCH COMPLAINT ID (B)(4), 4TH INCIDENT: 07-MARCH COMPLAINT ID (B)(4) AND 5TH INCIDENT: 08-MARCH COMPLAINT ID (B)(4). PATIENT IDENTIFIERS ARE NOT AVAILABLE. SAME PRODUCT INFORMATION FOR EACH INCIDENT ALL PATIENTS WERE NOT RE-STUCK, AN ADDITIONAL TUBE WAS FILLED REQUEST FOR 1 CASE OF REPLACEMENT PRODUCT OF A DIFFERENT LOT".

    Additional Manufacturer Narrative · 1

    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 VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ARE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 363080 BATCH NO. 9002613. IT WAS REPORTED THAT THE TUBES ARE OVERFILLING. 1ST INCIDENT: 04-MARCH (COMPLAINT ID (B)(4)) 2ND INCIDENT: 05-MARCH (COMPLAINT ID (B)(4)) 3RD INCIDENT: 06-MARCH (COMPLAINT ID (B)(4)) 4TH INCIDENT: 07-MARCH (COMPLAINT ID (B)(4)) 5TH INCIDENT: 08-MARCH (COMPLAINT ID (B)(4)) PATIENT IDENTIFIERS ARE NOT AVAILABLE. SAME PRODUCT INFORMATION FOR EACH INCIDENT. ALL PATIENTS WERE NOT RE-STUCK, AN ADDITIONAL TUBE WAS FILLED. REQUEST FOR 1 CASE OF REPLACEMENT PRODUCT OF A DIFFERENT LOT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246948 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9002613 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other