BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE¿ X225L PR YELLOW

    MDR report key: 8936215 · Received August 27, 2019

    Report

    Report Number
    3001741852-2019-00036
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    May 16, 2018
    Report Date
    August 27, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: CONFIRMED, NOT PART OF SPECIFICATION. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS ABLE TO CONFIRM THE DETECTION AND CHARACTERIZE THE CONDITION REPORTED BY THE CUSTOMER. BATCH RECORD REVIEW: THE BATCH 1736987 MET THE ACCEPTANCE CRITERIA WHEN SHIPPED. THE MANUFACTURING PROCESS IS NOT UNDER INVESTIGATION FOR THIS COMPLAINT. ROOT CAUSE DESCRIPTION: DURING SUPPLIER INVESTIGATION IT WAS FOUND THAT THE WRONG BOXES HAD BEEN LABELED WITH NOT FOR HUMAN USE (NFHU) DUE TO HUMAN ERROR. THE PROCEDURE ALSO DID NOT MENTION THAT PERFORMANCE QUALIFICATION PARTS ARE NOT TO BE IDENTIFIED AS NFHU AT THAT TIME. THE CUSTOMER HAS BEEN NOTIFIED OF THIS ISSUE AND HAVE BEEN INFORMED THAT THE PARTS CAN BE USED FOR HUMAN USE. THE CUSTOMER ALSO QUESTIONED THE EXPIRY DATE ON THE LABELS; THIS WAS ALSO COMMUNICATED BACK THAT BD USES A STANDARD FORMAT OF YYMMDD. THIS ISSUE HAS NOT BEEN PREVIOUSLY IDENTIFIED AND WILL BE REGISTERED IN THE QUALITY SYSTEMS FOR TRENDING PURPOSES. RATIONALE: CONFIRMED, NOT PART OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE LABEL HAD AN INCORRECT EXPIRATION LATE AS WELL AS LABELED "NOT FOR HUMAN USE WITH A BD ULTRASAFE¿ X225L PR YELLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2) THE RECEIPT OF YELLOW PLUNGER RODS HAS TWO ISSUES PREVENTING FORMAL RECEIPT AS DETAILED BELOW: THE EXPIRATION DATE OF THE COMPONENTS IS IN QUESTION. THE PRODUCT LABEL STATES 230118 WHICH IMPLIES THE MATERIALS EXPIRED 23/JAN/2018. THERE WAS NO COFA ISSUED WITH SHIPPING PAPERWORK AS PER THE ATTACHED DOCUMENTATION. THE PRODUCT IS LABELED ¿NOT FOR HUMAN USE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731933 BD ULTRASAFE¿ X225L PR YELLOW ANTISTICK SYRINGE MEG BECTON DICKINSON 1736987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other