BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

    MDR report key: 8737588 · Received June 26, 2019

    Report

    Report Number
    2027111-2019-00493
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    February 5, 2019
    Report Date
    September 3, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915126773
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THAT THERE WAS A HOLE IN THE TYVEK OF THE POUCH. BASED ON THE CONDITION OF THE RETURNED UNIT, THE REPORTED EVENT WAS CAUSED BY IMPROPER HANDLING. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM [DISTRIBUTOR] TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: JANUARY 29, 2019. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. I) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. (1) PRINTING ERROR (POUCH) - C0R47 - LOT# 1343405 & C0R47 LOT# 1342829 - COMPLAINT# 2019-001217 (2) POUCH TORN - CD004 LOT# 1341963 - COMPLAINT# 2019-001218 TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE EVENT.

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM [DISTRIBUTOR] TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: JANUARY 29, 2019. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. I) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. PRINTING ERROR (POUCH) - C0R47 - LOT# 1343405 & C0R47 LOT# 1342829 - COMPLAINT#: (B)(4). POUCH TORN - CD004 LOT# 1341963 - COMPLAINT#: (B)(4). TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527382 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD004 1341963 00607915126773

    Patients

    Seq Age Sex Outcome Treatment
    1