BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 3SS CV BV

    MDR report key: 12437327 · Received September 8, 2021

    Report

    Report Number
    2243072-2021-02255
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 10, 2021
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE AS LVP 20D 3SS CV BV TUBING CAME APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ENTERED PATIENT'S ROOM AND FOUND THAT IV TUBING HAD COME APART IN A SECTION THAT SHOULD HAVE BEEN FUSED. THE PORTION DISTAL TO THE MOST DISTAL ACCESS PORT WAS STILL CONNECTED TO PATIENT'S IV. THE REST OF THE TUBING WAS STILL IN THE PUMP. IV RATE WAS 30 ML/HR. THE BED WAS NOT WET. I ASSUME THE SEPARATION WAS RECENT. I FLUSHED THE IV AND FOUND IT WAS FUNCTIONING. I CHANGED THE IV BAG AND TUBING. I HAVE SAVED THE BROKEN TUBING.". D2: MEDICAL DEVICE BRAND NAME: AS LVP 20D 3SS CV BV. D2: MEDICAL DEVICE MANUFACTURER: BD SWITZERLAND SARL TIJUANA. D4: MEDICAL DEVICE CATALOG # 11522558. D4: MEDICAL DEVICE LOT #: 21045547. D4: UDI # (B)(4). G2: MANUFACTURING LOCATION: BD SWITZERLAND SARL TIJUANA. G.5. PMA / 510(K)#: K944320. H4: DEVICE MANUFACTURE DATE: 2021-04-06. INVESTIGATION SUMMARY: ONE USED PRIMARY SET WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD BE OBSERVED THAT THE BASE OF THE SET'S BOTTOM SMARTSITE NEEDLELESS CONNECTOR WAS DISCONNECTED FROM THE TUBING. NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT THE IV TUBING HAD COME APART IN A SECTION THAT SHOULD HAVE BEEN FUSED WAS VERIFIED. THE MATERIAL AND LOT NUMBER WAS ABLE TO BE DETERMINED USING THE COMPONENT NUMBER ON THE RETURNED SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 11522558 LOT NUMBER 21045547 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 29APR2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON BOTH THE INTERNAL AND EXTERNAL TUBING ENGAGEMENT COMPONENTS. IT COULD BE IDENTIFIED THAT THE SOLVENT HAD NOT BEEN PROPERLY APPLIED TO THE TUBING DURING THE ASSEMBLY PROCESS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS LVP 20D 3SS CV BV TUBING CAME APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ENTERED PATIENT'S ROOM AND FOUND THAT IV TUBING HAD COME APART IN A SECTION THAT SHOULD HAVE BEEN FUSED. THE PORTION DISTAL TO THE MOST DISTAL ACCESS PORT WAS STILL CONNECTED TO PATIENT'S IV. THE REST OF THE TUBING WAS STILL IN THE PUMP. IV RATE WAS 30 ML/HR. THE BED WAS NOT WET. I ASSUME THE SEPARATION WAS RECENT. I FLUSHED THE IV AND FOUND IT WAS FUNCTIONING. I CHANGED THE IV BAG AND TUBING. I HAVE SAVED THE BROKEN TUBING.".

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ INFUSION SET IV TUBING CAME APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ENTERED PATIENT'S ROOM AND FOUND THAT IV TUBING HAD COME APART IN A SECTION THAT SHOULD HAVE BEEN FUSED. THE PORTION DISTAL TO THE MOST DISTAL ACCESS PORT WAS STILL CONNECTED TO PATIENT'S IV. THE REST OF THE TUBING WAS STILL IN THE PUMP. IV RATE WAS 30 ML/HR. THE BED WAS NOT WET. I ASSUME THE SEPARATION WAS RECENT. I FLUSHED THE IV AND FOUND IT WAS FUNCTIONING. I CHANGED THE IV BAG AND TUBING. I HAVE SAVED THE BROKEN TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335690 AS LVP 20D 3SS CV BV INTRAVASCULAR ADMINISTRATION SET FPA 21045547

    Patients

    Seq Age Sex Outcome Treatment
    1