BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETOUCH COLLECTION SYSTEM (10/PK)

    MDR report key: 16493517 · Received March 7, 2023

    Report

    Report Number
    3003790304-2023-00102
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Report Date
    November 8, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HHI
    UDI-DI
    00821925037885
    PMA / PMN Number
    K030935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THE CUSTOMER RECEIVED THE SUBJECT DEVICE PAST THE EXPIRATION DATE; HOWEVER; THE SUBJECT DEVICE DOES NOT HAVE AN EXPIRATION DATE. IT WAS COMMUNICATED TO THE CUSTOMER THAT THIS DATE WAS THE DATE THE SUBJECT DEVICE WAS MANUFACTURED AND THE DEVICE IS SAFE TO USE. THERE IS NO REPORTABLE EVENT OR MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    TECHNICAL ASSISTANCE CENTER (TAC) COMMUNICATION WITH THE CUSTOMER REPRESENTATIVE REPORTED THAT THE ISSUE WAS NOTICED WEEKS AGO AND THE SUBJECT DEVICE WAS REMOVED FROM INVENTORY. A RETURN AUTHORIZATION MATERIAL (RMA) WAS ISSUED TO THE CUSTOMER FOR THE RETURN OF THE DEVICE. IN A FOLLOW UP COMMUNICATION, CUSTOMER STATED THAT THE BOX ONLY HAS ONE DATE STATING, "I THINK IT WAS MISTAKEN AS AN EXPIRATION INSTEAD OF A DATE OF MANUFACTURE." TO DATE, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER SERVICE REPRESENTATIVE REPORTED A POTENTIAL OUT OF BOX FAILURE; DEVICE WAS REPORTED TO FAIL UPON INSTALLATION. ACCORDING TO THE REPORT, THE DEVICE 003984-901 BERKELEY SAFETOUCH COLLECTION SYSTEM WITH TISSUE TRAPS CASE WAS SHIPPED IN DECEMBER, AND THE EXPIRATION DATE IS NOVEMBER, MAKING THE COLLECTION SYSTEM UNUSABLE. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716301 SAFETOUCH COLLECTION SYSTEM (10/PK) ABORTION SUCTION SYSTEM COLLECTION BOTTLE HHI GYRUS ACMI, INC. 003984-901 2070101 00821925037885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown