BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 10139043 · Received June 10, 2020

    Report

    Report Number
    1917413-2020-00488
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 21, 2020
    Report Date
    July 22, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. DUE TO NO SAMPLES AND/ OR PHOTOS BEING RECEIVED, THE MANUFACTURING INVESTIGATION WAS LIMITED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AT THE MANUFACTURING SITE BASED ON THIS INVESTIGATION. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION( CAPA# (B)(6)) HAS BEEN OPENED TO EVALUATE POOR BARRIER SEPARATION COMPLAINTS. TECHNICAL SERVICES DETERMINED THAT THE CUSTOMER WAS NOT CENTRIFUGING THIS PRODUCT ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THEY ADVISED THE FOLLOWING: SPEED AND TIME FOR THIS TUBE ARE 1500-1800 RCF FOR AT LEAST 20 MINUTES. A REVIEW OF SPECIMEN HANDLING PARAMETERS WOULD BE OF VALUE FOR THIS TUBE TYPE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBES WITH SODIUM HEPARIN EXPERIENCED POOR BARRIER SEPARATION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE RECEIVED : (B)(6)2020 MATERIAL NO. (B)(6), BATCH NO. 9240563, 9240565 RECEIVED CALL FROM SALES REP WANTING TO INQUIRE ON ANY MODIFICATIONS TO PRODUCT 362753 AS THEY'RE CUSTOMER IS REPORTING "BROKEN GEL BARRIERS" WITH LOTS 9240563 AND 9240565. REP IS UNAWARE OF ANY ADDITIONAL INFORMATION OTHER THAN THE ISSUE BUT THEY CAN FORWARD INFORMATION REQUEST LETTER TO THEIR CUSTOMER TO POSSIBLY GET ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ZIP: (B)(6). (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9240563, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2019-08-28, MEDICAL DEVICE LOT #: 9240565, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. 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 AN UNSPECIFIED NUMBER OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBES WITH SODIUM HEPARIN EXPERIENCED POOR BARRIER SEPARATION AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE RECEIVED : 21-MAY-2020. MATERIAL NO. 362753, BATCH NO. 9240563, 9240565. RECEIVED CALL FROM SALES REP WANTING TO INQUIRE ON ANY MODIFICATIONS TO PRODUCT 362753 AS THEY'RE CUSTOMER IS REPORTING "BROKEN GEL BARRIERS" WITH LOTS 9240563 AND 9240565. REP IS UNAWARE OF ANY ADDITIONAL INFORMATION OTHER THAN THE ISSUE BUT THEY CAN FORWARD INFORMATION REQUEST LETTER TO THEIR CUSTOMER TO POSSIBLY GET ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605127 BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362753 SEE H10 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other