BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR

    MDR report key: 15097479 · Received July 25, 2022

    Report

    Report Number
    3003916417-2022-00119
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1151864 MEDICAL DEVICE EXPIRATION DATE: 2022-09-30 DEVICE MANUFACTURE DATE: 2021-06-23 MEDICAL DEVICE LOT #: 1151863 MEDICAL DEVICE EXPIRATION DATE: 2022-09-30 DEVICE MANUFACTURE DATE: 2021-06-23 MEDICAL DEVICE LOT #: 1243384 . MEDICAL DEVICE EXPIRATION DATE: 2022-12-31.DEVICE MANUFACTURE DATE: 2021-10-08. 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: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022-08-11. H6: INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES RECEIVED AND 1 PHOTOS RECEIVED FOR EVALUATION FOR THE BATCH 1151864. NO SAMPLES OR PHOTOS FOR BATCHES 1151863 AND 1243384 WERE MADE AVAILABLE. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 5 RETENTION SAMPLES FROM EACH LOT OF THE BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. 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 BASED OF THE PHOTO EVIDENCE PROVIDED HOWEVER, THE ISSUE OF UNDERFILL COULD NOT BE REPLICATED IN THE RETENTION SAMPLE TESTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE NOT ASPIRATING THE QUANTITY PURPOSED. THE BLOOD DOESN'T REACH THE MARK."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE NOT ASPIRATING THE QUANTITY PURPOSED. THE BLOOD DOESN'T REACH THE MARK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711308 BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown