• 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 NPVC CATHETER

  • 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 NPVC CATHETER Back to Search Results
Catalog Number 383069
Device Problem Leak/Splash (1354)
Patient Problem Extravasation (1842)
Event Date 10/30/2019
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. (b)(4).
 
Event Description
It was reported that intima-ii y 22 ga x 1. 00 in prn ec slm npvc was used and the patient experienced extravasation. The following information was provided by the initial reporter: the patient was hospitalized due to trauma. Plain ct scan of the whole abdomen showed space-occupying lesion in the left lobe of the liver. Enhancement is suggested. On (b)(6) 2019, at 11:45 am, the patient and his family came to the imaging department to prepare for a total abdominal enhanced ct after needle injection and skin test of iodine allergy. The patient was ready after medication infusion, and the scan began at 11:57 am. The technician found that the monitored blood vessels in the scanning image were not bright, and the patient was stopped. After explaining the reason to the patient, the technician and the nurse went in to find the liquid extravasation and the patient's arm was swollen. They asked the patient to go back to the ward and informed the doctor and the nurse in the ward at 12:00. The nurse in the ward gave magnesium sulfate powder + flumesone 10 mg wet application, cold application of scutellin cream, and raised the patient's arm. 30 tension appeared in the swelling of the arm, blisters of different sizes appeared at 18:00, the blisters were punctured, pumped and disinfected at 20:30, the blisters became smaller on the (b)(6), no blisters appeared on (b)(6), the swelling was significantly reduced in the afternoon, and the swelling was slightly reduced on (b)(6). 2020-08-19 received update sales representative pir form, event description update is as follows: confirmed information with the hospital: the place where the leakage occurred was the rupture of the connecting tube between the indwelling needle and the heparin cap. There was no high-resolution photo or sample returned. At that time, a high-pressure syringe was used at a rate of 3 ml/s. The swelling in the patient's arm was unrelated to iodine allergy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC
Type of DeviceCATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10430527
MDR Text Key212358904
Report Number3006948883-2020-00362
Device Sequence Number1
Product Code FPA
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/07/2021
Device Catalogue Number383069
Device Lot Number8141361
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 Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2018
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: 08/20/2020 Patient Sequence Number: 1
-
-