BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSET,Y CONN,SPIKE. D

    MDR report key: 10932842 · Received December 2, 2020

    Report

    Report Number
    2243072-2020-01980
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). THE REPORTED LOT # [12699424] WAS NOT FOUND IN SAP FOR THE REPORTED CATALOG # [120-160XYSK]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: A 120-160XYSK PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 12699424. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT APPEARS THAT A PIECE OF PLASTIC WAS IDENTIFIED WITHIN THE INFUSION LINE AFTER ONE HOUR OF INFUSION, AND THAT THE UP ALARMED FOR AIR/UP OCCLUSION ALARM. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 12699424 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED OCCURRENCE WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 120-160XYSK PRODUCT OVER THE PAST 12 MONTHS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT WAS NOT POSSIBLE TO DETERMINE THE EXACT NATURE OF THE CONTAMINATION, NOR WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. RATIONALE: CME ARE THE LEGAL MANUFACTURER OF THIS DEVICE AND HAVE THE RESPONSIBILITY FOR ASSESSING THE CLINICAL RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN WHITE PARTICLE WAS FOUND "1/4 OF THE WAY DOWN" THE DISTAL SECTION OF THE MICROSET,Y CONN,SPIKE. D INFUSION SET AFTER THE 'AIR IN LINE' ALARM SOUNDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT CALLED TO REPORT THAT DURING SELF-ADMINISTRATION OF HER PRESCRIBED HYQVIA (SC IMMUNOGLOBULIN) AT HOME ON (B)(6) 2020 HER BODYGUARD PUMP ALARMED ¿AIR IN LINE¿. ON INSPECTION SHE & HER HUSBAND NOTED ¿A WHITE PIECE OF PLASTIC/PARTICLE¿ IN THE TUBING OF THE BODYGUARD ADMINISTRATION SET (BD 120-160XYXS: BATCH NO: 12699424). THE PARTICLE WAS NOTED APPROX. ¿1/4 OF THE WAY DOWN¿ THE DISTAL SECTION OF THE INFUSION SET, (LEADING FROM THE PUMP TO THE PATIENT)." "THE PATIENT IMMEDIATELY CLAMPED THE ¿HIGH FLOW¿ NEEDLE DEVICE SITUATED IN HER ABDOMEN & CHANGED THE ADMINISTRATION SET, THUS PREVENTING POSSIBLE INFUSION OF THE ¿PARTICLE¿. THE INITIAL ADMINISTRATION SET WAS PLACED INTO A SHARPS BIN & THE HYQVIA INFUSION PROCEEDED WITHOUT EVENT. THE PATIENT REPORTED THAT VIALS OF HYQVIA & ALL ANCILLARY ITEMS WERE INSPECTED/CHECKED PRIOR TO USE & NOTHING ABNORMAL WAS DETECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397927 MICROSET,Y CONN,SPIKE. D INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1