BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SINGLE USE NON-STACKABLE HOLDER

    MDR report key: 12125041 · Received July 6, 2021

    Report

    Report Number
    2243072-2021-01814
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 15, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. B.5. DESCRIBE EVENT OF PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER SST TUBE GEL 3.5 ML, THE DEVICE EXPERIENCED THE HOLDER SEPARATING FROM THE NON-PATIENT END NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN REPLY OF PR# 3040364, THE CUSTOMER MENTIONS THAT THE TUBES DON'T ADAPT PERFECTLY TO THE DEVICE, AND SOMETIMES THEY RELEASE FROM THE SUPPORT, BUT SHE COMMENTS THAT THEY'VE IDENTIFIED THAT THE ISSUE COULD POSSIBLY BE RELATED TO THE NEEDLE, SINCE IT OCCURS JUST WITH THE FIRST TUBE TO BE INSERTED INTO THE HOLDER. THE PUNCTURE DEVICE WAS NOT BD, THE BRAND USED NOWADAYS IS WILTEX, BUT THE HOLDER IS BD. D.1: BRAND NAME: BD VACUTAINER SST TUBE GEL 3.5 ML. D.3. MANUFACTURER NAME, CITY AND STATE: BECTON DICKINSON IND. CIRURGICAS LTDA. D.4. CATALOG: 360059. D.4. UNIQUE IDENTIFIER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SINGLE USE NON-STACKABLE HOLDER, THE DEVICE EXPERIENCED THE HOLDER SEPARATING FROM THE NON-PATIENT END NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN REPLY OF PR# 3040364, THE CUSTOMER MENTIONS THAT THE TUBES DON'T ADAPT PERFECTLY TO THE DEVICE, AND SOMETIMES THEY RELEASE FROM THE SUPPORT, BUT SHE COMMENTS THAT THEY'VE IDENTIFIED THAT THE ISSUE COULD POSSIBLY BE RELATED TO THE NEEDLE, SINCE IT OCCURS JUST WITH THE FIRST TUBE TO BE INSERTED INTO THE HOLDER. THE PUNCTURE DEVICE WAS NOT BD, THE BRAND USED NOWADAYS IS WILTEX, BUT THE HOLDER IS BD. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SINGLE USE NON-STACKABLE HOLDER MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW) MEDICAL DEVICE CATALOG #: 364815 MEDICAL DEVICE LOT #: 0030622 UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW) PMA / 510(K)#: PREAMENDMENT DEVICE MANUFACTURE DATE: 01/30/2020 INVESTIGATION: BD DID NOT RECEIVE A CUSTOMER SAMPLE HOWEVER, 1 VIDEO WAS RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE VIDEO WAS EVALUATED AND SHOWS THE TUBE PUSHING BACK OFF THE NEEDLE IN THE HOLDER. IT WAS ALSO OBSERVED IN THE VIDEO THAT THE ACQUISITION NEEDLE USED IS NOT A BD PRODUCT AND, IT IS NOT KNOWN IF THE ACQUISITION NEEDLE USED BY THE CUSTOMER IS COMPATIBLE WITH THE 364815 HOLDER. ADDITIONALLY, 8 SAMPLES FROM THE BD INVENTORY WERE FUNCTIONALLY EVALUATED WITH NO ISSUES BEING IDENTIFIED. THESE RETENTION SAMPLE HOLDERS WERE TESTED BY INSERTING A NEEDLE THAT IS USED BY THE MANUFACTURING PLANT AND IS A KNOWN COMPATIBLE COMPONENT WITH THE HOLDER AND THE SAME TUBE TYPE THAT WAS USED BY THE CUSTOMER WITH NO ISSUES BEING OBSERVED. 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. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FROM THE VIDEO PROVIDED; HOWEVER, THE VIDEO DOES SHOW THAT THE TUBE IS BEING PUSHED OFF OF THE NEEDLE. THE NEEDLE AND TUBES BEING USED IN THE VIDEO ARE NOT MANUFACTURED AT THIS SITE. H3 OTHER TEXT :

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER SST TUBE GEL 3.5 ML, THE DEVICE EXPERIENCED THE HOLDER SEPARATING FROM THE NON-PATIENT END NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN REPLY OF PR# 3040364, THE CUSTOMER MENTIONS THAT THE TUBES DON'T ADAPT PERFECTLY TO THE DEVICE, AND SOMETIMES THEY RELEASE FROM THE SUPPORT, BUT SHE COMMENTS THAT THEY'VE IDENTIFIED THAT THE ISSUE COULD POSSIBLY BE RELATED TO THE NEEDLE, SINCE IT OCCURS JUST WITH THE FIRST TUBE TO BE INSERTED INTO THE HOLDER. THE PUNCTURE DEVICE WAS NOT BD, THE BRAND USED NOWADAYS IS WILTEX, BUT THE HOLDER IS BD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SINGLE USE NON-STACKABLE HOLDER, THE DEVICE EXPERIENCED THE HOLDER SEPARATING FROM THE NON-PATIENT END NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN REPLY OF PR# 3040364, THE CUSTOMER MENTIONS THAT THE TUBES DON'T ADAPT PERFECTLY TO THE DEVICE, AND SOMETIMES THEY RELEASE FROM THE SUPPORT, BUT SHE COMMENTS THAT THEY'VE IDENTIFIED THAT THE ISSUE COULD POSSIBLY BE RELATED TO THE NEEDLE, SINCE IT OCCURS JUST WITH THE FIRST TUBE TO BE INSERTED INTO THE HOLDER. THE PUNCTURE DEVICE WAS NOT BD, THE BRAND USED NOWADAYS IS WILTEX, BUT THE HOLDER IS BD.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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. 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 IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THE DEVICE EXPERIENCED THE HOLDER SEPARATING FROM THE NON-PATIENT END NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN REPLY OF PR# (B)(4), THE CUSTOMER MENTIONS THAT THE TUBES DON'T ADAPT PERFECTLY TO THE DEVICE, AND SOMETIMES THEY RELEASE FROM THE SUPPORT, BUT SHE COMMENTS THAT THEY'VE IDENTIFIED THAT THE ISSUE COULD POSSIBLY BE RELATED TO THE NEEDLE, SINCE IT OCCURS JUST WITH THE FIRST TUBE TO BE INSERTED INTO THE HOLDER. THE PUNCTURE DEVICE WAS NOT BD, THE BRAND USED NOWADAYS IS WILTEX, BUT THE HOLDER IS BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022208 BD VACUTAINER SINGLE USE NON-STACKABLE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0030622

    Patients

    Seq Age Sex Outcome Treatment
    1