• 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) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR 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) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383408
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported with the use of the bd intima-ii¿ closed iv catheter system there was an issue with the catheter being broken. It was stated ¿the patient was a (b)(6) old man or woman, entered the hospital for operation because of fracture. On (b)(6), the patient began to use catheter, the punctured point was on the right-hand. No abnormality was found after infusion on 12:00 am of (b)(6). When nurse prepared to infusion and flush the catheter on 17: 00 pm, nurse found water exudate from application and removed the application and found catheter broken. Then scanned on the patient on 18:00 pm and found blurred image in the 1/3 right- arm of patient. The patient was transferred to shanxi other hospital to find the broken part. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
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
8015652845
MDR Report Key7484550
MDR Text Key107314126
Report Number3006948883-2018-00066
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2020
Device Catalogue Number383408
Device Lot Number7142043
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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: 05/03/2018 Patient Sequence Number: 1
-
-