• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR ADMINISTRATION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 383019
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyanosis (1798); Chills (2191)
Event Date 05/22/2021
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that the patient developed chills, shortness of breath, and cyanosis while using intima-ii y 22gax1. 00in prn/ec slm. The following information was provided by the initial reporter: at 9:45 am on (b)(6) 2021, the patient developed sudden chills, chills, shortness of breath, and cyanosis of the skin of the whole body while administering 0. 9%ns 250ml+ vitamin c injection 2g+ potassium chloride injection 0. 79g. T36. 9, p133 times/min, r32 times/min, bp130/78mmhg. The infusion of reorganized drug was stopped immediately, and the infusion set was replaced. Ecg monitoring and oxygen saturation monitoring were performed, and oxygen inhalation was performed. 25mg of promethazine hydrochloride injection was given intramuscular sedation, and 10mg of dexamethasone sodium phosphate injection was injected for anti-allergy. The patient's symptoms were improved after light treatment. 10:10 was t38. 9, and 4ml of bupleurum injection and 0. 1 of compound aminobarbital were injected intramuscularly to cool the temperature. 10:25 t39. 0 was re-measured and vital signs were continued. 12:00 t37. 0¿ p88 times/min,r21 times/min, bp120/70mmhg.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTIMA-II Y 22GAX1.00IN PRN/EC SLM
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12072073
MDR Text Key264973365
Report Number3006948883-2021-00707
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/24/2021
Device Catalogue Number383019
Device Lot Number8305823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 06/25/2021 Patient Sequence Number: 1
-
-