BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 10752100 · Received October 28, 2020

    Report

    Report Number
    2243072-2020-01746
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: B.1. ADVERSE EVENT OR PRODUCT PROBLEM B.5. DESCRIBE EVENT OR PROBLEM D.1. MEDICAL DEVICE BRAND NAME: BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA D.4. MEDICAL DEVICE CATALOG #: 360060 MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9304692 D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31 H.4. DEVICE MANUFACTURE DATE: 2019-11-21 D.4. MEDICAL DEVICE LOT #: 0140513 D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31 H.4. DEVICE MANUFACTURE DATE: 2020-06-19 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR G.4. 510K #: NA H.1. TYPE OF REPORTBLE EVENTS: SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. THEREFORE, TUBES FROM BD MANUFACTURING LINE WERE EVALUATED DURING IN-PROCESS TESTING AND IT WAS IT WAS FOUND THAT THE STOPPERS COME LOOSE ON THEIR OWN. EVEN THOUGH NO SAMPLES WERE PROVIDED TO TEST FOR UNDERFILL, A LOOSE STOPPER MAY LEAD TO INADEQUATE DRAW. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER THE STOPPER PULLED OUT OF THE TUBE WITHIN A HOLDER, THE STOPPER POPPED OUT OF THE TUBE, AND UNDERFILL/LOW DRAW OCCURRED. THE CUSTOMER REPORTED THE PATIENT WAS INJURED. HOWEVER, NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBES OPEN DURING COLLECTION. THEY DO NOT COLLECT THE PROPER VOLUME OF THE TUBE. DURING THE TRANSPORT OF THE SAMPLE THE TUBES ARE OPENING. AS IT IS NOT KNOWN WHICH OF THE TWO SKUS HAD THE DEVIATION, IT IS REGISTERED IN THE PRODUCT GRID AS AN UNKNOWN CATALOG. IT IS REPORTED THAT DUE TO SLOWNESS OF BLOOD COLLECTION, SOMETIMES THEY NEED TO PUNCTURE THE PATIENT TWICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER THE STOPPER PULLED OUT OF THE TUBE WITHIN A HOLDER, THE STOPPER POPPED OUT OF THE TUBE, AND UNDERFILL/LOW DRAW OCCURRED. THE CUSTOMER REPORTED THE PATIENT WAS INJURED. HOWEVER, NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBES OPEN DURING COLLECTION. THEY DO NOT COLLECT THE PROPER VOLUME OF THE TUBE. DURING THE TRANSPORT OF THE SAMPLE THE TUBES ARE OPENING. AS IT IS NOT KNOWN WHICH OF THE TWO SKUS HAD THE DEVIATION, IT IS REGISTERED IN THE PRODUCT GRID AS AN UNKNOWN CATALOG. IT IS REPORTED THAT DUE TO SLOWNESS OF BLOOD COLLECTION, SOMETIMES THEY NEED TO PUNCTURE THE PATIENT TWICE.

    Additional Manufacturer Narrative · 1

    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)(4) HAS BEEN LISTED AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL CATALOG NUMBER: THERE WERE 2 POTENTIAL TUBES ASSOCIATED WITH THIS EVENT. HOWEVER, THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH TUBE HAD THE DEVIATION. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER THE STOPPER PULLED OUT OF THE TUBE WITHIN A HOLDER, THE STOPPER POPPED OUT OF THE TUBE, AND UNDERFILL/LOW DRAW OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBES OPEN DURING COLLECTION. THEY DO NOT COLLECT THE PROPER VOLUME OF THE TUBE. DURING THE TRANSPORT OF THE SAMPLE THE TUBES ARE OPENING. AS IT IS NOT KNOWN WHICH OF THE TWO SKUS HAD THE DEVIATION, IT IS REGISTERED IN THE PRODUCT GRID AS AN UNKNOWN CATALOG. IT IS REPORTED THAT DUE TO SLOWNESS OF BLOOD COLLECTION, SOMETIMES THEY NEED TO PUNCTURE THE PATIENT TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217728 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other