BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    MDR report key: 11675893 · Received April 15, 2021

    Report

    Report Number
    9617032-2021-00344
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION? YES. D.11. D.11.RETURNED TO MANUFACTURER ON: 2021-06-07. H.3. DEVICE EVALUATED BY MANUFACTURER? YES. H.4. DEVICE MANUFACTURE DATE: YES. H.6. INVESTIGATION SUMMARY: BD RECEIVED 30 SAMPLES FOR INVESTIGATION. TWENTY (20) SAMPLES FROM MATERIAL # 368815, LOT # 0161176 WERE EVALUATED BY DRAW TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. FROM THE DRAW TESTING IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. ADDITIONALLY, 20 RETENTION SAMPLES FROM EACH LOT # (0161176 AND 0225020) FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H.9. ACTION REPORTED TO FDA: B01, B02, B14. H.9. ACTION REPORTED TO FDA: C19. H.9. ACTION REPORTED TO FDA: D14 H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: IMDRF ANNEX B GRID (3) B17, B02, B14. IMDRF ANNEX C GRID (1) :C19. IMDRF ANNEX D GRID (1): D14. H.4. REASON CODE FOR NO EVALUATION: OTHER. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM EACH LOT NUMBER (0161176 AND 0225020) FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE TUBE DID NOT FILL THE REQUIRED AMOUNT OF BLOOD."

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE TUBE DID NOT FILL THE REQUIRED AMOUNT OF BLOOD. IT HAPPENED TO TWO LOTS 0161176 AND 0225020."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0161176, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2020-06-09. MEDICAL DEVICE LOT #: 0225020, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2020-08-12. 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 THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE TUBE DID NOT FILL THE REQUIRED AMOUNT OF BLOOD. IT HAPPENED TO TWO LOTS 0161176 AND 0225020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567511 BD VACUTAINER CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1