BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9695149 · Received February 11, 2020

    Report

    Report Number
    1920898-2020-00108
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR PRE-ACTIVATION WITH THE INCIDENT LOT WAS OBSERVED, HOWEVER FAILURE MODE FOR DAMAGED TUBING WAS NOT 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 DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS REPORTED THAT THE NEEDLE HAD ACTIVATED PREMATURELY AND THE TUBING WAS KINKED AT THE HUB OF THE BUTTERFLY. EVENT DESCRIPTION PER ATTACHED SFDC PIR STATES: BUTTERFLY ¿ PUSH BUTTON BLOOD COLLECTION SET REF 367324 LOT# 9162775 EXP 2021-06-30. THE SAFETY DEVICE WAS ALREADY ENGAGED AND A KINK THAT IS TOWARDS THE END OF THE TUBING RIGHT AT THE HUB OF THE BUTTERFLY UNIT. HARD TO SEE ON PICTURE. ISSUES ON MONDAY, (B)(6) 2020 AND ALSO ON FRIDAY, (B)(6) 2020.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WAS ACTIVATED PREMATURELY AND HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS REPORTED THAT THE NEEDLE HAD ACTIVATED PREMATURELY AND THE TUBING WAS KINKED AT THE HUB OF THE BUTTERFLY. EVENT DESCRIPTION PER ATTACHED SFDC PIR STATES: BUTTERFLY ¿ PUSH BUTTON BLOOD COLLECTION SET REF (B)(4) LOT# 9162775 EXP 2021-06-30. THE SAFETY DEVICE WAS ALREADY ENGAGED AND A KINK THAT IS TOWARDS THE END OF THE TUBING RIGHT AT THE HUB OF THE BUTTERFLY UNIT. HARD TO SEE ON PICTURE. ISSUES ON MONDAY, 1/20/2020 AND ALSO ON FRIDAY, 1/10/2020.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS REPORTED THAT THE NEEDLE HAD ACTIVATED PREMATURELY AND THE TUBING WAS KINKED AT THE HUB OF THE BUTTERFLY. EVENT DESCRIPTION PER ATTACHED SFDC PIR STATES: BUTTERFLY ¿ PUSH BUTTON BLOOD COLLECTION SET REF 367324 LOT# 9162775 EXP 2021-06-30. THE SAFETY DEVICE WAS ALREADY ENGAGED AND A KINK THAT IS TOWARDS THE END OF THE TUBING RIGHT AT THE HUB OF THE BUTTERFLY UNIT. HARD TO SEE ON PICTURE. ISSUES ON MONDAY, (B)(6) 2020 AND ALSO ON FRIDAY, (B)(6) 2020.¿

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WAS ACTIVATED PREMATURELY AND HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IT WAS REPORTED THAT THE NEEDLE HAD ACTIVATED PREMATURELY AND THE TUBING WAS KINKED AT THE HUB OF THE BUTTERFLY. EVENT DESCRIPTION PER SFDC PIR STATES: BUTTERFLY ¿ PUSH BUTTON BLOOD COLLECTION SET REF 367324 LOT# 9162775 EXP 2021-06-30. THE SAFETY DEVICE WAS ALREADY ENGAGED AND A KINK THAT IS TOWARDS THE END OF THE TUBING RIGHT AT THE HUB OF THE BUTTERFLY UNIT. HARD TO SEE ON PICTURE. ISSUES ON MONDAY, (B)(6) 2020 AND ALSO ON FRIDAY, (B)(6) 2020.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160348 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BD MEDICAL - DIABETES CARE 367324 9162775 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other