BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD A-LINE¿

    MDR report key: 18902938 · Received March 14, 2024

    Report

    Report Number
    9617032-2024-00364
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 20, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643566
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3151661 D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025 H4. DEVICE MANUFACTURE DATE: 31-MAY-2023 D4. MEDICAL DEVICE LOT#: UNKNOWN D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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

    H.6 INVESTIGATION SUMMARY. MATERIAL #: 364356. LOT/BATCH #: 3151661 AND UNKNOWN. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED FOR THEIR HEPARIN CONTENT AND NO ISSUES WERE OBSERVED RELATING TO CLOTTING 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD A-LINE¿, CLOTTING WAS SEEN IN 5 SYRINGES WITH A KNOWN LOT NUMBER AND AN UNSPECIFIED NUMBER OF SYRINGES WITH UNKNOWN LOT NUMBERS. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD A-LINE¿, CLOTTING WAS SEEN IN 5 SYRINGES WITH A KNOWN LOT NUMBER AND AN UNSPECIFIED NUMBER OF SYRINGES WITH UNKNOWN LOT NUMBERS. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969540 BD A-LINE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903643566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown