BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8832314 · Received July 26, 2019

    Report

    Report Number
    2243072-2019-01506
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 9, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET TUBING "ABOUT 1 INCH FROM" THE NEEDLE PROTECTION DEVICE WAS DAMAGED AND BLOOD "GUSHED" FROM THE AREA DURING USE. THE CUSTOMER REPORTED 2 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEFECT WAS ON THE LENGTH OF THE TUBING CLOSEST TO THE NEEDLE PROTECTION DEVICE THAT WE ATTACH TO IT; ABOUT 1 INCH FROM IT. IT WAS HARD TO SEE WHAT EXACTLY IT WAS; WHETHER IT WAS A HOLE, OR SLIT AS THE BLOOD WAS GUSHING OUT OF THE AREA."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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 THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. THE REPORTED LOT # [8253781] WAS NOT FOUND FOR THE REPORTED CATALOG # [367344]. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET TUBING "ABOUT 1 INCH FROM" THE NEEDLE PROTECTION DEVICE WAS DAMAGED AND BLOOD "GUSHED" FROM THE AREA DURING USE. THE CUSTOMER REPORTED 2 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEFECT WAS ON THE LENGTH OF THE TUBING CLOSEST TO THE NEEDLE PROTECTION DEVICE THAT WE ATTACH TO IT; ABOUT 1 INCH FROM IT. IT WAS HARD TO SEE WHAT EXACTLY IT WAS; WHETHER IT WAS A HOLE, OR SLIT AS THE BLOOD WAS GUSHING OUT OF THE AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624313 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other