BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 11033188 · Received December 17, 2020

    Report

    Report Number
    9616066-2020-20600
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    August 18, 2020
    Report Date
    January 11, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A 2000E CHINA SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT THE SMARTSITE BROKE AT THE POINT WHERE THE FEMALE LUER ADAPTER (FLA) MEETS THE CLEAR BODY OF THE SMARTSITE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19095442 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) CONNECTOR FRACTURED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THERE HAVE BEEN SEVERAL INFUSION CONNECTOR FRACTURE INCIDENTS IN THIS DEPARTMENT RECENTLY. THE LAST COMPLAINT WAS ON JULY 13 WITH THE COMPLAINT CODE AS (B)(4). TODAY, ANOTHER FRACTURE ACCIDENT OCCURRED. CLINICAL CUSTOMERS SERIOUSLY SUSPECTED THAT THE BATCH OF JOINTS HAD QUALITY PROBLEMS. TODAY¿S EXERCISE TOOK PLACE AT AROUND 9 AM. THE CHILD WAS BORN 4 DAYS AFTER THE PICC TUBE WAS PLACED. THE PICC TUBE BRAND IS UNKNOWN (THE CUSTOMER DID NOT GIVE FEEDBACK, BECAUSE IT IS A NEONATOLOGY DEPARTMENT, SALES CANNOT GO TO THE SITE FOR INSPECTION), ON THE FIRST DAY OF USE,THE INFUSION CONNECTOR BREAK OCCURRED. AFTER INVESTIGATION, THERE ARE STILL 325 OF THIS BATCH IN THE NEONATOLOGY DEPARTMENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT. K960280. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) CONNECTOR FRACTURED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THERE HAVE BEEN SEVERAL INFUSION CONNECTOR FRACTURE INCIDENTS IN THIS DEPARTMENT RECENTLY. THE LAST COMPLAINT WAS ON JULY 13 WITH THE COMPLAINT CODE AS PR#: (B)(4). TODAY, ANOTHER FRACTURE ACCIDENT OCCURRED. CLINICAL CUSTOMERS SERIOUSLY SUSPECTED THAT THE BATCH OF JOINTS HAD QUALITY PROBLEMS. TODAY¿S EXERCISE TOOK PLACE AT AROUND 9 AM. THE CHILD WAS BORN 4 DAYS AFTER THE PICC TUBE WAS PLACED. THE PICC TUBE BRAND IS UNKNOWN (THE CUSTOMER DID NOT GIVE FEEDBACK, BECAUSE IT IS A NEONATOLOGY DEPARTMENT, SALES CANNOT GO TO THE SITE FOR INSPECTION), ON THE FIRST DAY OF USE,THE INFUSION CONNECTOR BREAK OCCURRED. AFTER INVESTIGATION, THERE ARE STILL 325 OF THIS BATCH IN THE NEONATOLOGY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496725 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1