BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HOLDER ONE USE

    MDR report key: 10164152 · Received June 17, 2020

    Report

    Report Number
    2243072-2020-00919
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 28, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/3/2020. H.6. INVESTIGATION: BD RECEIVED 7 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR A MOLDING DEFECT WITH THE INCIDENT LOT WAS 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHARP MOLDING DEFECT WAS DISCOVERED ON WING WITH A BD HOLDER ONE USE. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT HAS BEEN REPORTED THAT A BURR ON WING IS DANGEROUS BECAUSE IT TOUCHES PATIENT¿S SKIN DURING BLOOD COLLECTION. OF HOSPITAL STOCKS, SOME (20-30) HAVE A BURR ON WING.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: NA. 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 THAT A SHARP MOLDING DEFECT WAS DISCOVERED ON WING WITH A BD HOLDER ONE USE. THIS OCCURRED ON 30 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT HAS BEEN REPORTED THAT A BURR ON WING IS DANGEROUS BECAUSE IT TOUCHES PATIENT¿S SKIN DURING BLOOD COLLECTION. OF HOSPITAL STOCKS, SOME (20-30) HAVE A BURR ON WING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629689 BD HOLDER ONE USE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 2002BD001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other