BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM / CAT BLOOD COLLECTION TUBE

    MDR report key: 11224382 · Received January 25, 2021

    Report

    Report Number
    1024879-2021-00044
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678193
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT SIX (6) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE MARKING, DAMAGED, MOLDING DEFECT AND FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. BASED ON THE REVIEW OF THE CUSTOMER PHOTOS AND INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED. THE MOST LIKELY CAUSE OF THE DEFECTIVE MARKING IS A FELT PAD USED FOR INK APPLICATION DISLODGING FROM THE LABELLING EQUIPMENT. AN INCOMPLETE LINE CLEARANCE DID NOT CULL ALL AFFECTED TUBES. THE DAMAGED HEMOGARD SHIELDS MOST LIKELY OCCURRED DURING AN EQUIPMENT JAM ON THE MANUFACTURING LINE. PURGING OF THE START-UP PARTS WAS NOT ADEQUATE WHICH ALLOWED THE FURTHER PROCESSING OF THE DAMAGED PARTS. THE FM EMBEDDED IN THE TUBE (SPOT IN TUBE) MOST LIKELY OCCURRED DURING THE INJECTION MOLDING START-UP PROCESS, WITH ADEQUATE PURGING OF THE LINE OCCURRING. THE MOST LIKELY CAUSE OF THE DIRTY TUBE WAS INK SMEARS AND IS A FELT PAD USED FOR INK APPLICATION DISLODGING FROM THE LABELLING EQUIPMENT. AN INCOMPLETE CLEARANCE DID NOT CULL ALL AFFECTED TUBES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBE EXPERIENCED FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL AND NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THE FOLLOWING ISSUES WERE FOUND IN TUBES (367819) FROM LOT 0122582: DEFECTIVE MARKING ×332. SPOT IN TUBE ×3. DIRTY TUBE ×1.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER¿ SERUM / CAT BLOOD COLLECTION TUBE EXPERIENCED FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL AND NO LABEL OR MISSING LABEL INFORMATION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THE FOLLOWING ISSUES WERE FOUND IN TUBES 367819 FROM LOT 0122582: DEFECTIVE MARKING ¿332, SPOT IN TUBE ¿3, DIRTY TUBE ¿1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118876 BD VACUTAINER SERUM / CAT BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367819 0122582 50382903678193

    Patients

    Seq Age Sex Outcome Treatment
    1