BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 11735030 · Received April 27, 2021

    Report

    Report Number
    9617032-2021-00380
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. NO CUSTOMER SAMPLES/PHOTOS WERE RECEIVED FOR EVALUATION. DUE TO AN UNKNOWN BATCH NUMBER AND THE UNAVAILABILITY OF CUSTOMER SAMPLES, THE ROOT CAUSE IS INDETERMINATE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD THE TUBE PUSH OFF THE NON PATIENT END OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 367342 BATCH NO: UNKNOWN (POSSIBLE LOTS 0324983, 0350790, 1011441, 0303017, 0324983, 0357207) IT WAS REPORTED THAT THE TUBE IS POPPING OFF THE NEEDLE. KIM VELASQUEZ : 2021-04-06 14:38:27 (GMT) THE STAFF HAD SEVERAL COMPLAINTS REGARDING THIS PRODUCT, SO I AM NOT SURE WHICH ONE YOU ARE ASKING ME TO DEFINE. THE TWO MAIN COMPLAINTS ARE THAT THE TUBES POP OFF SOMETIMES AND YOU HAVE TO PHYSICALLY HOLD THE TUBE ON THE NEEDLE TO FILL; THE OTHER IS THAT WHEN YOU ARE IN THE VEIN, A BUBBLE OF AIR WILL TRAVEL DOWN THE TUBING EVEN AFTER YOU HAVE HAD SUCCESSFUL FLOW. ITEM #367342 23G PUSH BUTTON COLLECTION SET. LOT NUMBERS: ¿ 0324983 ¿ 0350790 ¿ 1011441 ¿ 0303017 ¿ 0324983 ¿ 0357207 THERE ARE NO SAMPLES FOR INVESTIGATION. I AM NOT SURE IF THE DEFECT CAUSED ANY PATIENTS TO BE REDRAWN. I WAS NOT GIVEN THAT INFORMATION. NO MEDICAL INTERVENTION."

    Additional Manufacturer Narrative · 1

    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 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD THE TUBE PUSH OFF THE NON PATIENT END OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 367342 BATCH NO: UNKNOWN (POSSIBLE LOTS 0324983, 0350790, 1011441, 0303017, 0324983, 0357207) IT WAS REPORTED THAT THE TUBE IS POPPING OFF THE NEEDLE. (B)(6) 2021 14:38:27 (GMT) THE STAFF HAD SEVERAL COMPLAINTS REGARDING THIS PRODUCT, SO I AM NOT SURE WHICH ONE YOU ARE ASKING ME TO DEFINE. THE TWO MAIN COMPLAINTS ARE THAT THE TUBES POP OFF SOMETIMES AND YOU HAVE TO PHYSICALLY HOLD THE TUBE ON THE NEEDLE TO FILL; THE OTHER IS THAT WHEN YOU ARE IN THE VEIN, A BUBBLE OF AIR WILL TRAVEL DOWN THE TUBING EVEN AFTER YOU HAVE HAD SUCCESSFUL FLOW. ITEM #367342 23G PUSH BUTTON COLLECTION SET. LOT NUMBERS: 0324983, 0350790, 1011441, 0303017, 0324983, 0357207. THERE ARE NO SAMPLES FOR INVESTIGATION. I AM NOT SURE IF THE DEFECT CAUSED ANY PATIENTS TO BE REDRAWN. I WAS NOT GIVEN THAT INFORMATION. NO MEDICAL INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628266 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367342 UNKNOWN 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1