BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 8965261 · Received September 5, 2019

    Report

    Report Number
    1024879-2019-01570
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR INCORRECT CAP COLOR WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND INCORRECT CAP COLOR WAS OBSERVED. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE ONE OF THE TUBES HAD AN INCORRECT CAP COLOR WITH A BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE THIS BATCH, WHEN CUSTOMER OPEN THE PACKAGE, THEY FOUND 1EA TUBE HAS INCORRECT CAP COLOR. D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. D.1 MEDICAL DEVICE TYPE: N/A. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND COMPANY (BD), PLYMOUTH, UNITED KINGDOM/ PL6 7BP. D.4 MEDICAL DEVICE CATALOG #: 363095. D.4. MEDICAL DEVICE LOT #: 9102594. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION: BECTON DICKINSON AND COMPANY (BD), PLYMOUTH, UNITED KINGDOM/ PL6 7BP. G.5. PMA / 510(K)#: N/A. H.4. DEVICE MANUFACTURE DATE: 2019-04-12 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE ONE OF THE TUBES HAD AN INCORRECT CAP COLOR WITH A BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE THIS BATCH, WHEN CUSTOMER OPEN THE PACKAGE, THEY FOUND 1EA TUBE HAS INCORRECT CAP COLOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE ONE OF THE TUBES HAD AN INCORRECT CAP COLOR WITH A BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE THIS BATCH, WHEN CUSTOMER OPEN THE PACKAGE, THEY FOUND 1EA. TUBE HAS INCORRECT CAP COLOR.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE ONE OF THE TUBES HAD AN INCORRECT CAP COLOR WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEFORE USE THIS BATCH, WHEN CUSTOMER OPEN THE PACKAGE, THEY FOUND 1EA TUBE HAS INCORRECT CAP COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761670 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9102594 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other