BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD

    MDR report key: 12001029 · Received June 15, 2021

    Report

    Report Number
    1024879-2021-00388
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903680450
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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 CANNOT MAKE ANY CLAIMS ABOUT THE USE OF EXPIRED TUBES. SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/22/2021. H.6. INVESTIGATION: BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND WAS CONFIRMED TO HAVE EXPIRED ON 2/28/2021. THE TUBE DID NOT HAVE ANY VISIBLE DEFECTS. 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 DOES NOT RECOMMEND AND CANNOT MAKE ANY CLAIMS ABOUT THE USE OF EXPIRED TUBES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® UNSPECIFIED BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD, THE USER NOTICED THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED, - "IT WAS FOUND OUT THAT EXPIRED BLOOD COLLECTION TUBES WERE USED TO COLLECT BLOOD FROM PATIENTS. WOULD YOU PLEASE LET US KNOW IF THIS WILL AFFECT OUR SAMPLE QUALITY?" ADDITIONAL INFORMATION RECEIVED 2021-06-09 12:31 PM: WAS THE PATIENT REDRAWN AND RE TESTED? NO O WHAT WAS THE RESULTS OF THE REPEAT TESTING? N/A O WAS THERE ANY MEDICAL INTERVENTION DUE TO ERRONEOUS RESULTS? N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® UNSPECIFIED BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD, THE USER NOTICED THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED, - "IT WAS FOUND OUT THAT EXPIRED BLOOD COLLECTION TUBES WERE USED TO COLLECT BLOOD FROM PATIENTS. WOULD YOU PLEASE LET US KNOW IF THIS WILL AFFECT OUR SAMPLE QUALITY?" ADDITIONAL INFORMATION RECEIVED 2021-06-09 12:31 PM: WAS THE PATIENT REDRAWN AND RE TESTED? NO. WHAT WAS THE RESULTS OF THE REPEAT TESTING? N/A. WAS THERE ANY MEDICAL INTERVENTION DUE TO ERRONEOUS RESULTS? N/A.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 WHEN USING THE BD VACUTAINER® UNSPECIFIED BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD, THE USER NOTICED THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED: "IT WAS FOUND OUT THAT EXPIRED BLOOD COLLECTION TUBES WERE USED TO COLLECT BLOOD FROM PATIENTS. WOULD YOU PLEASE LET US KNOW IF THIS WILL AFFECT OUR SAMPLE QUALITY?" ADDITIONAL INFORMATION RECEIVED 2021-06-09 12:31 PM: WAS THE PATIENT REDRAWN AND RE TESTED? NO. WHAT WAS THE RESULTS OF THE REPEAT TESTING? N/A. WAS THERE ANY MEDICAL INTERVENTION DUE TO ERRONEOUS RESULTS? N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901017 BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9070659 00382903680450

    Patients

    Seq Age Sex Outcome Treatment
    1