BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11003168 · Received December 14, 2020

    Report

    Report Number
    2243072-2020-02054
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 16, 2020
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-04. H6: INVESTIGATION SUMMARY: ONE OE0420R SAMPLE FROM LOT 202036 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER¿S EXPERIENCE AS A SMALL CRACK WAS IDENTIFIED AT THE JOINT OF THE SMARTSITE TO THE VIAL ACCESS DEVICE (VAD); THE CONNECTION BETWEEN THE TWO COMPONENTS WAS FOUND TO BE SECURE AND DID NOT DISCONNECT UNDER MANUAL MANIPULATION. FUNCTIONAL TESTING WAS PERFORMED WITH A RETAINED BD 50ML SYRINGE AND NO LEAKAGE WAS OBSERVED AT THE SITE OF THE CRACK. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, YUKON MEDICAL LLC, FOR INVESTIGATION. ANALYSIS OF THE MANUFACTURING PROCESS DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE OBSERVED CRACK; HOWEVER IT IS POSSIBLE THAT SIMILAR DAMAGE CAN OCCUR ON START-UP OF THE ASSEMBLY MACHINERY. TYPICALLY THESE PRODUCTS ARE SEGREGATED AND DISPOSED OF, HOWEVER IN THIS INSTANCE IT APPEARS THAT THE PRODUCT CONTINUED ON TO SUBSEQUENT ASSEMBLY STEPS DUE TO DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 202036 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OEM SS 20MM VENTED VIAL ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE ANOTHER COMPLAINT WHICH IS THE SAME/SIMILAR TO THE DEFECT IN 201001_PPR LIST. THIS IS ALSO THE SAME PRODUCT AS THE ¿CRACKED FILTER¿ FILED IN 201101_PPR FOR P /N OE0420R . THE ISSUES ALL SEEM TO BE SUPPLIER RELATED AND WE NEED TO DETERMINE THE ISSUES, BECAUSE WE ARE CURRENTLY (1) MANUFACTURING, (2) TRYING TO FULFILL THE BACKORDER. WE CURRENTLY HAVE 3,000 PCS IN STOCK, LOT 202028 WHICH IS THE SAME LOT TERUMO HAS A COMPLAINT AGAINST. I NEED TO DETERMINE IF WE NEED TO PULL THIS STOCK BACK AND RTV. BUT I NEED CONFIRMATION THIS LOT IS IN FACT ¿DEFECTIVE¿.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OEM SS 20MM VENTED VIAL ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE ANOTHER COMPLAINT WHICH IS THE SAME/SIMILAR TO THE DEFECT IN 201001_PPR LIST. THIS IS ALSO THE SAME PRODUCT AS THE ¿CRACKED FILTER¿ FILED IN 201101_PPR FOR P /N OE0420R . THE ISSUES ALL SEEM TO BE SUPPLIER RELATED AND WE NEED TO DETERMINE THE ISSUES, BECAUSE WE ARE CURRENTLY (1) MANUFACTURING, (2) TRYING TO FULFILL THE BACKORDER. WE CURRENTLY HAVE 3,000 PCS IN STOCK, LOT 202028 WHICH IS THE SAME LOT TERUMO HAS A COMPLAINT AGAINST. I NEED TO DETERMINE IF WE NEED TO PULL THIS STOCK BACK AND RTV. BUT I NEED CONFIRMATION THIS LOT IS IN FACT ¿DEFECTIVE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467566 OEM SS 20MM VENTED VIAL ACCESS DEVICE SET, I.V. FLUID TRANSFER LHI BECTON DICKINSON 202036

    Patients

    Seq Age Sex Outcome Treatment
    1