BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 16235692 · Received January 24, 2023

    Report

    Report Number
    1024879-2023-00029
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 8, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.3 MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD) D.4. MEDICAL DEVICE LOT #: 22195502. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. H.4. DEVICE MANUFACTURE DATE: 2022-07-14. G.1. MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD) H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ILLEGIBLE IV SHIELD PRINT WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO ILLEGIBLE IV SHIELD PRINT 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 ILLEGIBLE IV SHIELD PRINT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1000 UNITS OF BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD ILLEGIBLE LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ALMOST ILLEGIBLE ENGRAVING OF LOT NUMBER AND EXPIRY INFORMATION ON THE DEVICE UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1000 UNITS OF BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD ILLEGIBLE LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ALMOST ILLEGIBLE ENGRAVING OF LOT NUMBER AND EXPIRY INFORMATION ON THE DEVICE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619523 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 2195502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown