BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 17803548 · Received September 22, 2023

    Report

    Report Number
    1024879-2023-00638
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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: D.4. MEDICAL DEVICE LOT #: 3153060. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H.4. DEVICE MANUFACTURE DATE: 02-JUN-2023. D.4. MEDICAL DEVICE LOT #: 3153061. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H.4. DEVICE MANUFACTURE DATE: 02-JUN-2023. D.4. MEDICAL DEVICE LOT #: 3153062. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H.4. DEVICE MANUFACTURE DATE: 02-JUN-2023. H.3. 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: D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 07-SEP-2023 H3. INVESTIGATION SUMMARY: BD RECEIVED 8 SAMPLES FROM LOT 3153062 AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH LOT 3153062 WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE SUBJECTED TO DRAW TESTING FOR LOW OR NO DRAW. ONLY 3 OUT OF THE 8 TUBES WERE ABLE TO BE TESTED, AS 5 OF THE TUBES WERE PREVIOUSLY USED. THE 3 REMAINING TUBES ALL TESTED WITHIN SPECIFICATION. RETENTION SAMPLES FROM ALL 3 LOTS WERE SUBJECTED TO DRAW TESTING FOR LOW OR NO DRAW. ALL SAMPLES WERE WITHIN SPECIFICATION. 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 NO VACUUM FOR LOT 3153062 BASED ON THE PHOTOS PROVIDED. ALL RETURN SAMPLE AND RETENTION SAMPLE TESTING WAS SATISFACTORY. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR NO VACUUM FOR LOT #'S 3153060 AND 3153061. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THE TUBES WERE UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT ITEM 367988, LOT# 3153062 HAS NO VACUUM. PICTURE RECEIVED DOES SHOW THERE WAS A LOW DRAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THE TUBES WERE UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT ITEM 367988, LOT# 3153062 HAS NO VACUUM. PICTURE RECEIVED DOES SHOW THERE WAS A LOW DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294479 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown