BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE RATED EXT SET BONDED SS 8.5

    MDR report key: 11826272 · Received May 14, 2021

    Report

    Report Number
    9616066-2021-50999
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 19, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403242043
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR SAMPLES (MODEL#: 22003E-07) WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT 3 EXTENSION SETS WILL NOT DRAW BLOOD OR FLUSH. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLES WERE CONNECTED TO A CUT OFF SYRINGE TIP TO CHECK THAT THE FLUID PATH IS IN AN ACTIVATED POSITION/OPEN WHEN CONNECTED TO A SYRINGE. THE SAMPLES WERE THEN FLUSHED WITH WATER USING A 10ML BD SYRINGE TO CONFIRM AN OPEN FLUID PATH. THE FLUID PATHS OF THE SAMPLES WERE OPEN AND THOSE SAMPLES WERE ABLE TO BE FLUSHED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL: 22003E-07, LOT NUMBER: 20119558 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 06NOV2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 PRESSURE RATED EXT SETS BONDED SS 8.5 FROM LOT: 20119558, AND 1 SET FROM AN UNSPECIFIED LOT WERE BLOCKED/OCCLUDED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 3 EXTENSION SETS IN MY OFFICE FROM A DIFFERENT LOT THAN THE 3 YOU WERE ALREADY INVESTIGATING (10)20109557."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20119558, MEDICAL DEVICE EXPIRATION DATE: 2021-11-03, DEVICE MANUFACTURE DATE: 2020-11-03. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 PRESSURE RATED EXT SETS BONDED SS 8.5 FROM LOT 20119558, AND 1 SET FROM AN UNSPECIFIED LOT WERE BLOCKED/OCCLUDED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 3 EXTENSION SETS IN MY OFFICE FROM A DIFFERENT LOT THAN THE 3 YOU WERE ALREADY INVESTIGATING (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724911 PRESSURE RATED EXT SET BONDED SS 8.5 INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22003E-07 SEE SECTION H.10. 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1