BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD A-LINE¿

    MDR report key: 13003381 · Received December 14, 2021

    Report

    Report Number
    9617032-2021-01285
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-04. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR CLOTTING WAS OBSERVED. ADDITIONALLY, THE 1 RETURNED AND 10 RETENTION SAMPLES FROM BD INVENTORY WERE ANALYZED FOR HEPARIN CONTENT AND THE ISSUE OF CLOTTING WAS NOT OBSERVED AS THE AMOUNT OF ANTI-COAGULANT MET SPECIFICATIONS IN BOTH THE RETURNED SAMPLE AND ALL RETENTION SAMPLES. 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 CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD A-LINE¿, BLOOD COAGULATED INSIDE THE SYRINGES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOD COAGULATES INSIDE A-LINE SYRINGES CAT#364356, LOT 1180919. MEDICAL WORKERS HAVE EXPERIENCE WITH THIS PRODUCT AND NEVER HAD ANY ISSUES BEFORE. BLOOD IS OBTAINED FROM CATHETERS ACCORDING TO LOCAL SOP (1. WASHED WITH SALINE 2. 2X DEAD VOLUMES OF BLOOD WERE REMOVED). SAMPLES WERE PROCESSED AS USUAL WITHIN 7 MINUTES, WITH IMMEDIATE MIXING AND NO STORAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD A-LINE¿, BLOOD COAGULATED INSIDE THE SYRINGES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOD COAGULATES INSIDE A-LINE SYRINGES CAT # 364356, LOT 1180919. MEDICAL WORKERS HAVE EXPERIENCE WITH THIS PRODUCT AND NEVER HAD ANY ISSUES BEFORE. BLOOD IS OBTAINED FROM CATHETERS ACCORDING TO LOCAL SOP (1. WASHED WITH SALINE 2. 2X DEAD VOLUMES OF BLOOD WERE REMOVED). SAMPLES WERE PROCESSED AS USUAL WITHIN 7 MINUTES, WITH IMMEDIATE MIXING AND NO STORAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896329 BD A-LINE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1180919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown