BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 16959239 · Received May 18, 2023

    Report

    Report Number
    9617032-2023-00567
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673365
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.1 MEDICAL DEVICE TYPE: FPA. D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. 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 DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-06-09. H.6. INVESTIGATION SUMMARY: "MATERIAL #: 367336. LOT/BATCH #: 2192978, 2248340, 2248338. BD RECEIVED 1 SAMPLE FROM LOT 2248338, 12 SAMPLES FROM LOT 2248340, 450 SAMPLES FROM LOT 2192978, AND (B)(4) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGED PACKAGING AND FOREIGN MATTER WERE OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODES FOR DAMAGED PACKAGING AND FOREIGN MATTER WITH THE INCIDENT LOT WERE OBSERVED. ADDITIONALLY, (B)(4) RETENTION SAMPLES OF EACH REPORTED LOT NUMBER FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF DAMAGED PACKAGING AND FOREIGN MATTER WERE NOT OBSERVED. 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 MODES DAMAGED PACKAGING AND FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK DIRT WAS FOUND ON THE BLOOD COLLECTION SET / FOREIGN BODY WAS FOUND INSIDE THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK DIRT WAS FOUND ON THE BLOOD COLLECTION SET / FOREIGN BODY WAS FOUND INSIDE THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510508 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367336 2248338 50382903673365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown