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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Model Number 383552
Device Problems Leak/Splash (1354); Material Separation (1562)
Patient Problem Hematoma (1884)
Event Date 06/10/2022
Event Type  Injury  
Event Description
It was reported that during use of the bd nexiva¿ closed iv catheter system, the iv broke and leakage occurred. The following information was provided by the initial reporter: "rn states that patient woke up and mentioned to the cna that her sheets were all wet and that she needed to use the commode, initially documented as bleeding from pt¿s forehead, but rn noticed that the blood was located around the pt¿s abdomen region not head region, pt had no wounds/lacs anywhere else except forehead. Pt got out of bed and sat on the commode. Rn noticed a lot of blood approx. 200-300 cc of blood on the sheets with clots. At that time patient while sitting on the commode also got diaphoretic and dizzy. Md was made aware and ordered iv fluid, when rn went to connect the ivf, she found the iv extension missing and in the picture was what was left attached to the patient. Md had ordered a new cbc d/t symptoms. Initial h&h on arrival 13/40. 4 repeat h&h after incident 11. 7/36. 2. Repeat cbc was drawn 90 mins after incident. Pt did receive 1l ivf though the night, it is also mentioned that patient did have a hematoma on head and lac, but was per md ¿ without any concerning findings. ".
 
Manufacturer Narrative
Medical device expiration date: unknown. Additional phone number: (b)(6). 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. ¿.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14964492
MDR Text Key295599692
Report Number9610847-2022-00255
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835523
UDI-Public(01)30382903835523
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383552
Device Catalogue Number383552
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/08/2022 Patient Sequence Number: 1
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