BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 13158684 · Received January 4, 2022

    Report

    Report Number
    9617032-2021-01350
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 9, 2021
    Report Date
    January 10, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1151180. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-06-03. MEDICAL DEVICE LOT #: 1069934. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2021-03-10. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-05. H6: INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE OF BATCH: 1069934 AND 18 SAMPLES OF BATCH: 1151180 AND 5 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR COCKED STOPPER AND UNDERFILL WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 19 RETAINED SAMPLES FROM BATCH: 1151180 AND 2 RETAINED SAMPLES BATCH: 1069934 FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF UNDERFILL AND STOPPER COCKED WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS.. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL AND STOPPER COCKED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING 42 OCCURRENCES OF STOPPER CREEP OUT AND UNDERFILL. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING USING THE TUBE, IT FOUND THAT THE TUBE OCCURRED STOPPER CREEP OUT AND LOW DRAW ISSUES. DUE TO LOOSE RUBBER PLUG, AFTER BLOOD COLLECTION IN THE SORTING MACHINE TUBE CAP OFF, RESULTING IN POLLUTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING 42 OCCURRENCES OF STOPPER CREEP OUT AND UNDERFILL. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING USING THE TUBE, IT FOUND THAT THE TUBE OCCURRED STOPPER CREEP OUT AND LOW DRAW ISSUES. DUE TO LOOSE RUBBER PLUG, AFTER BLOOD COLLECTION IN THE SORTING MACHINE TUBE CAP OFF, RESULTING IN POLLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884320 BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown