BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 13563898 · Received February 18, 2022

    Report

    Report Number
    1024879-2022-00097
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 25, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FPA. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0057975. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-02-26. MEDICAL DEVICE LOT #: 0050079. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-02-19. MEDICAL DEVICE LOT #: 0083018. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2020-03-23. MEDICAL DEVICE LOT #: 0093254. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2020-04-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION?: YES D.9. RETURNED TO MANUFACTURER ON: 24-FEB-2022 H.6. INVESTIGATION: BD RECEIVED 1 PHOTO AND 7 SAMPLES FROM THE CUSTOMER FOR REVIEW AND EVALUATION. BOTH THE PHOTO AND CUSTOMER SAMPLES WERE EVALUATED AND CONFIRM THE REPORTED ISSUE OF A BRITTLE SLEEVE AS THE SLEEVE APPEARS DRY AND CRACKED. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS AND CUSTOMER SAMPLES. BASED ON A REVIEW OF BATCH RECORDS, AND INVESTIGATION RESULTS NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. 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. ROOT CAUSE CAN'T BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE USER EXPERIENCED POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FROM THE CUSTOMER: WE HAD AROUND NINE SETS THAT THE RUBBER IS BRITTLE AROUND THE CONNECTION ON THE TRANSFER END. I HAVE BEEN ADVISED THAT THEY ARE 367342 AND CAME FROM LOT NUMBERS 0057975, 0050079, 0083018 AND 0093254 WITH EXPIRATION DATES OF 02/28/22 AND 03/03/22. I HAVE ASKED FOR THE NINE SETS (INDIVIDUAL) TO BE SENT TO ME. I SHOULD HAVE THEM TO SEND BACK IF NEEDED. THEY USED A DIFFERENT WINGSET TO DRAW, NO INJURIES WERE NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE USER EXPERIENCED POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FROM THE CUSTOMER: WE HAD AROUND NINE SETS THAT THE RUBBER IS BRITTLE AROUND THE CONNECTION ON THE TRANSFER END. I HAVE BEEN ADVISED THAT THEY ARE (B)(4) AND CAME FROM LOT NUMBERS 0057975, 0050079, 0083018 AND 0093254 WITH EXPIRATION DATES OF 02/28/22 AND 03/03/22. I HAVE ASKED FOR THE NINE SETS (INDIVIDUAL) TO BE SENT TO ME. I SHOULD HAVE THEM TO SEND BACK IF NEEDED. THEY USED A DIFFERENT WINGSET TO DRAW, NO INJURIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334361 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10. 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown