BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK INDEFLATOR

    MDR report key: 13225755 · Received January 11, 2022

    Report

    Report Number
    2024168-2022-00364
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 20, 2021
    Report Date
    March 16, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    UDI-DI
    08717648013973
    PMA / PMN Number
    K961471
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PPAK DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS HOWEVER THIS COMPLAINT APPEARS TO BE RELATED TO A MANUFACTURING ISSUE ASSOCIATED WITH LEAK ISSUES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ONE NONCONFORMING MATERIAL RECORD/EXCEPTION WAS GENERATED FOR THE FINISHED GOOD LOT TO INVESTIGATE THE REPORTED ISSUE IN ACCORDANCE WITH INTERNAL OPERATING PROCEDURES. A REVIEW OF THE COMPLAINT HISTORY REVEALED 4 OTHER SIMILAR INCIDENTS. THE INVESTIGATION DETERMINED THE REPORTED LEAK APPEARS TO BE A POTENTIAL PRODUCT QUALITY ISSUE. ON FEB 25TH, 2022 ABBOTT VASCULAR DECIDED TO INITIATE A VOLUNTARY FIELD ACTION FOR THIS PRODUCT. ABBOTT VASCULAR SUBMITTED MEDWATCH # 2024168-2022-01831 ON MARCH 4, 2022 WITH NOTIFICATION OF THE VOLUNTARY RECALL IN H7, (REMEDIAL ACTION INITIATED). CORRECTIVE ACTION HAS BEEN INITIATED PER SITE OPERATING PROCEDURES. THE PRODUCT WILL CONTINUE TO BE TRENDED. ON MARCH 4TH, 2022, ABBOTT VASCULAR NOTIFIED A FOREIGN COMPETENT AUTHORITY OF A FIELD SAFETY CORRECTIVE ACTION FOR SPECIFIC LOTS OF 20/30 AND PLUS 30 INDEFLATORS AND ASSOCIATED PRIORITY PACKS: 20/30 PRIORITY PACK WITH COPLIOT, 20/30 PRIORITY PACK, PRIORITY PACK 20/30 W/115 RHV, PPAK 20/30 WITH RHV, PLUS 30, PPAKPLUS30, PPAKPLUS30 W/115 RHV. THIS ACTION IS BEING TAKEN DUE TO AN INCREASE IN THE COMPLAINT TREND FOR REPORTED DEVICE CODE 1354, LEAK/SPLASH AND (RDC) 1371 LOOSE OR INTERMITTENT CONNECTION. 20/30 INDEFLATORS ARE AT AN INCREASED RISK OF LEAKING DUE TO A GAP IN THE HOSE SNAP FITTING. STOPCOCKS ARE AT AN INCREASED RISK OF LEAKING DUE TO A HIGHER TENDENCY FOR LOOSE CONNECTIONS WHEN NOT CONNECTED PROPERLY.D9- DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, TWO INDEFLATORS FAILED TO HOLD SEAL [LEAK]. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625605 20/30 PRIORITY PACK INDEFLATOR ACCESSORIES MAV ABBOTT VASCULAR 1003327 60322147 08717648013973

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown