BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9648179 · Received January 30, 2020

    Report

    Report Number
    1024879-2020-00034
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 10, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673655
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED DURING USE WITH A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT COMPLETELY. IT WAS ALSO REPORTED THAT TWO BUTTERFLIES WERE RETRACTED IN THE PACKAGE. PER EMAIL: SINCE (B)(6) , I HAVE RECEIVED THE FOLLOWING COMPLAINTS FROM (B)(4) DIFFERENT COLLECTION AREAS REGARDING THE PRODUCTS LISTED BELOW. EACH OF THE ITEMS WERE DISPOSED, EXCEPT FOR THE 25G BUTTERFLY, SO I WILL NEED TO RETURN THAT ITEM. - 21 G; BD #367365; LOT #9150625; INPATIENT TECH REPORTED THAT NEEDLE FAILED TO RETRACT COMPLETELY INTO THE HUB WHEN BUTTON WAS PUSHED; NO INJURY OCCURRED - 21 G; BD #367365; LOT #9158945; INPATIENT TECH REPORTED THAT 2 BUTTERFLIES WERE RETRACTED IN THE PACKAGE; NO INJURY OCCURRED" 1 OF 3 COMPLAINTS. 3 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9150625. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9158945. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-06-07. 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 THAT RETRACTION FAILURE OCCURRED DURING USE WITH A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT COMPLETELY. IT WAS ALSO REPORTED THAT TWO BUTTERFLIES WERE RETRACTED IN THE PACKAGE. PER EMAIL: SINCE DECEMBER 6TH, I HAVE RECEIVED THE FOLLOWING COMPLAINTS FROM 2 DIFFERENT COLLECTION AREAS REGARDING THE PRODUCTS LISTED BELOW. EACH OF THE ITEMS WERE DISPOSED, EXCEPT FOR THE 25G BUTTERFLY, SO I WILL NEED TO RETURN THAT ITEM. 21 G; BD #367365; LOT #9150625; INPATIENT TECH REPORTED THAT NEEDLE FAILED TO RETRACT COMPLETELY INTO THE HUB WHEN BUTTON WAS PUSHED; NO INJURY OCCURRED. 21 G; BD #367365; LOT #9158945; INPATIENT TECH REPORTED THAT 2 BUTTERFLIES WERE RETRACTED IN THE PACKAGE; NO INJURY OCCURRED." 1 OF 3 COMPLAINTS. 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113712 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367365 SEE. H.10 50382903673655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other