BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD EDTA BLOOD COLLECTION TUBES

    MDR report key: 17647307 · Received August 29, 2023

    Report

    Report Number
    2243072-2023-01525
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    May 11, 2022
    Report Date
    September 29, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. PATIENT¿S BLOOD CAN REACT WITH TUBE ADDITIVES IN RARE CASES. EDTA- AND CITRATE-DEPENDENT PSEUDOTHROMBOCYTOPENIA (PTCP) ARE AN INFREQUENT PHENOMENON OF IN VITRO PLATELET CLUMPING THAT HAVE BEEN PREVIOUSLY REPORTED IN LITERATURE. BD HAS PREVIOUSLY IDENTIFIED THIS AS A POTENTIAL PRODUCT LIMITATION AND PLANS TO ADD A STATEMENT TO THE INSTRUCTIONS FOR USE (IFU) REGARDING THE POTENTIAL FOR ADDITIVE-DEPENDENT PSEUDOTHROMBOCYTOPENIA IN RARE PATIENT POPULATIONS WHEN USING BD VACUTAINER® TUBES WITH THE EDTA OR CITRATE ADDITIVE. A CHANGE CONTROL WAS OPENED TO MANAGE AND TRACK THE UPDATES TO THE IFU. AS IFU UPDATES ASSOCIATED WITH ADDITIVE-INDUCED PSEUDOTHROMBOCYTOPENIA ARE ALREADY BEING ADDRESSED THROUGH A CHANGE CONTROL, NO FURTHER INVESTIGATION IS REQUIRED SPECIFIC TO THIS ARTICLE. HOWEVER, COMPLAINTS (EDTA: CASE # 02101947; CITRATE: CASE # (B)(4)) WERE SUBMITTED TO DOCUMENT THE ADDITIVE-INDUCED PSEUDOTHROMBOCYTOPENIA OBSERVED IN SAMPLES COLLECTED USING BD VACUTAINER® EDTA AND CITRATE TUBES. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING AN UNKNOWN BD EDTA BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT TUBE PLATELET IS CLUMPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT ARTICLE REVIEW OBSERVING: EDTA-INDUCED PSEUDOTHROMBOCYTOPENIA/ EDTA-INDUCED PLATELET CLUSTERS. IF SALESFORCE PIR COMPLAINT, DATE EMAIL RECEIVED: NA. CUSTOMER PROBLEM: ARTICLE REVIEW OBSERVING: EDTA-INDUCED PSEUDOTHROMBOCYTOPENIA/ EDTA-INDUCED PLATELET CLUSTERS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NA. ARTICLE ATTACHED FOR REFERENCE. CUSTOMER LOCATION (COUNTRY): USA. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? UNKNOWN. DID EXPOSURE TO BLOOD/ BF OCCUR? UNKNOWN. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? UNKNOWN. NEXT STEPS (IF NECESSARY): NONE, ARTICLE REVIEW. RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: UNKNOWN. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): UNKNOWN. IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD¿ WHO IS IT? UNKNOWN. PHOTOS OR RETURNS REQUESTED?: NA. FOLLOW UP REQUIRED (Y/N)?: N. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING AN UNKNOWN BD EDTA BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT TUBE PLATELET IS CLUMPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT ARTICLE REVIEW OBSERVING: EDTA-INDUCED PSEUDOTHROMBOCYTOPENIA/ EDTA-INDUCED PLATELET CLUSTERS. IF SALESFORCE PIR COMPLAINT, DATE EMAIL RECEIVED: NA CUSTOMER PROBLEM: ARTICLE REVIEW OBSERVING: EDTA-INDUCED PSEUDOTHROMBOCYTOPENIA/ EDTA-INDUCED PLATELET CLUSTERS STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NA. ARTICLE ATTACHED FOR REFERENCE CUSTOMER LOCATION (COUNTRY): USA DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? UNKNOWN DID EXPOSURE TO BLOOD/ BF OCCUR? UNKNOWN IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? UNKNOWN NEXT STEPS (IF NECESSARY): NONE, ARTICLE REVIEW RESOLUTION ACHIEVED (Y/N)? : N QUANTITY RECEIVED AND QUANTITY AFFECTED: UNKNOWN SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): UNKNOWN IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD¿ WHO IS IT? UNKNOWN PHOTOS OR RETURNS REQUESTED?: NA FOLLOW UP REQUIRED (Y/N)?: N HAZARD, INJURY OR ERRONEOUS RESULTS? NO HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815926 UNKNOWN BD EDTA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown