BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE RATED EXT SET BONDED SS 8.5"

    MDR report key: 12207330 · Received July 21, 2021

    Report

    Report Number
    9616066-2021-51600
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 22, 2021
    Product Code
    FPA
    UDI-DI
    50885403242043
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 41 USED SAMPLES WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. EACH SMARTSITE WAS ATTACHED TO A CUT OFF BD SYRINGE TO SEE IF A FLUID PATH CAN BE OBSERVED WHILE THE PISTON IS IN THE ACTIVATED POSITION. A FLUID PATH WAS OBSERVED FOR 28 SMARTSITES WHILE THE PISTON WAS IN THE ACTIVATED POSITION. 13 SMARTSITES DID NOT SHOW A FLUID PATH WHILE THE PISTON WAS IN THE ACTIVATED POSITION. THOSE 13 SAMPLES VERIFIED THE CUSTOMER COMPLAINT THAT THERE WERE FAILED EXTENSION SETS DURING EMERGENT TRAUMA. THE SMARTSITES THAT OBSERVED A FLUID PATH WERE THEN CONNECTED TO A 10 ML BD SYRINGE FILLED WITH BLUE DYE WATER AND THE SETS WERE ATTEMPTED TO BE FLUSHED. THE SETS WERE SUCCESSFULLY FLUSHED. THOSE 28 SAMPLES DID NOT VERIFY THE CUSTOMER COMPLAINT THAT THERE WERE FAILED EXTENSION SETS DURING EMERGENT TRAUMA. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 20119617 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 18NOV2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 20119639 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 26NOV2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) 1998036 HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 41 PRESSURE RATED EXT SET BONDED SS 8.5" WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE COLLECTED AT LEAST 35-40 FAILED EXTENSION SETS OVER THE LAST SEVERAL WEEKS AS PART OF A PRODUCT CONCERN PROCESS. LAST NIGHT WE HAD 3 REPEATED FAILED EXTENSION SETS DURING AN EMERGENT TRAUMA TRANSFER, DELAYING PATIENT CARE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20119617, MEDICAL DEVICE EXPIRATION DATE: 2021-11-18, DEVICE MANUFACTURE DATE: 2020-11-17, MEDICAL DEVICE LOT #: 20119639, MEDICAL DEVICE EXPIRATION DATE: 2021-11-25, DEVICE MANUFACTURE DATE: 2020-11-24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 41 PRESSURE RATED EXT SET BONDED SS 8.5" WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE COLLECTED AT LEAST 35-40 FAILED EXTENSION SETS OVER THE LAST SEVERAL WEEKS AS PART OF A PRODUCT CONCERN PROCESS. LAST NIGHT WE HAD 3 REPEATED FAILED EXTENSION SETS DURING AN EMERGENT TRAUMA TRANSFER, DELAYING PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098625 PRESSURE RATED EXT SET BONDED SS 8.5" INTRAVASCULAR ADMINISTRATION SET FPA 22003E-07 UNKNOWN 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1