BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GRAVITY SET

    MDR report key: 18789515 · Received February 27, 2024

    Report

    Report Number
    9616066-2024-00328
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 30, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY CUSTOMER THAT HE PRODUCT DOES NOT ALLOW FLUID THROUGH THE SPIKE ADAPTER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. NO ROOT CAUSE DEFINITION WAS DETERMINATE DUE TO THE CUSTOMER DID NOT PROVIDE A SAMPLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL DYNDTN1545 LOT NUMBER 23065159 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 12JUN2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD GRAVITY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAD A COUPLE COMPLAINTS FOR DYNDTN1545 REGARDING THE PRODUCT NOT ALLOWING FLOW OF MEDICATION AND CONTAMINATION. I PUT THE DETAILS OF THE COMPLAINTS BELOW WITH PHOTOS. 200594503: THEY SPIKE THE BAG WITH THE PRIMARY, AND IT WON'T FLOW. MULTIPLE NURSES WERE LOOKING AND CHECKING IT OUT, NOTHING WAS CLAMPED, OR KINKED. LOT: 23095709 200595915: THE PRODUCT DOES NOT ALLOW FLUID THROUGH THE SPIKE ADAPTER. LOT: 23065070 200594732: LINE 10 DYNDTN1545 - PER TONY MOK TIN STONE FOUND INSIDE THE TUBE OF IV TUBING 15 DROP. LOT 23065159; EXP 60-67-2026. FOR THE FIRST TWO WE DID TEST ABOUT 13 SAMPLES FROM THOSE TWO COMPLAINTS AND DID CONFIRM THAT TWO HAD ISSUES WITH DELIVERING FLUID FROM THE DRIP CHAMBER. IT LOOKED LIKE THERE WAS EXCESSIVE BONDING AGENT MAY HAVE BEEN APPLIED THAT CAUSED THE ISSUE WITH FLOW.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: DYNDTN1545 BATCH#: 23065070 IT WAS REPORTED BY CUSTOMER THAT HE PRODUCT DOES NOT ALLOW FLUID THROUGH THE SPIKE ADAPTER. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAD A COUPLE COMPLAINTS FOR DYNDTN1545 REGARDING THE PRODUCT NOT ALLOWING FLOW OF MEDICATION AND CONTAMINATION. I PUT THE DETAILS OF THE COMPLAINTS BELOW WITH PHOTOS. 200594503: THEY SPIKE THE BAG WITH THE PRIMARY, AND IT WON'T FLOW. MULTIPLE NURSES WERE LOOKING AND CHECKING IT OUT, NOTHING WAS CLAMPED, OR KINKED. LOT: 23095709 200595915: THE PRODUCT DOES NOT ALLOW FLUID THROUGH THE SPIKE ADAPTER. LOT: 23065070 200594732: LINE 10 DYNDTN1545 - PER (B)(6) TIN STONE FOUND INSIDE THE TUBE OF IV TUBING 15 DROP. LOT 23065159; EXP 60-67-2026. FOR THE FIRST TWO WE DID TEST ABOUT 13 SAMPLES FROM THOSE TWO COMPLAINTS AND DID CONFIRM THAT TWO HAD ISSUES WITH DELIVERING FLUID FROM THE DRIP CHAMBER. IT LOOKED LIKE THERE WAS EXCESSIVE BONDING AGENT MAY HAVE BEEN APPLIED THAT CAUSED THE ISSUE WITH FLOW. COMMENTS ON 20/03/2024 THE SAMPLE FOR (B)(4) IS HERE IN VERNON HILLS. TESTING WAS CONDUCTED AND THE FAILURE REPORTED COULD NOT BE VERIFIED. ALTHOUGH THERE IS A KINK IN THE TUBING, THE INFUSION SET ALLOWS FOR GOOD FLUID FLOW. THE FAILURE OF OCCLUSION COULD NOT BE VERIFIED. PLEASE LET ME KNOW IF YOU WOULD LIKE FOR ME TO FORWARD THE SAMPLES. WE HAVE YET TO RECEIVE A SAMPLE FOR (B)(4). IT LOOKS AS IF A SHIPPING LABEL HAD NOT BEEN PROVIDED TO THE CUSTOMER FOR THE PHYSICAL SAMPLE. I HAVE REQUESTED THE RCC TEAM TO PROVIDE A SHIPPING LABEL FOR THAT SAMPLE. FOR (B)(4) WE HAVE NOT RECEIVED A PHYSICAL SAMPLE, HOWEVER, THE CUSTOMER HAS PROVIDED A PHOTO. WE CAN CONFIRM THAT THERE APPEARS TO BE FOREIGN MATTER ON THE DRIP CHAMBER BASED ON THE PHOTO, HOWEVER, WE WILL MOST LIKELY NOT BE ABLE TO FORWARD THE INVESTIGATION TO THE SUPPLIER BECAUSE OF THE LACK OF A PHYSICAL SAMPLE. I WILL FORWARD THE INFORMATION TO THE SQE TEAM AND SEE IF THE SUPPLIER WILL STILL CONDUCT AN INVESTIGATION WITH ONLY A PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669691 BD GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23065159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown