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

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported when using the bd intima-ii¿ closed iv catheter system the catheter broke/separated from hub. The following information was provided by the initial reporter. The customer stated: "in pediatrics, the product could not be removed when the catheter tube was pulled out of the patient's arm, and it was pulled out the next day after hot compress one night. The puncture site was in the head of the child. After pulling out, the naked eye could see abnormal short catheter. ".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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 when using the bd intima-ii¿ closed iv catheter system the catheter broke/separated from hub. The following information was provided by the initial reporter. The customer stated: "in pediatrics, the product could not be removed when the catheter tube was pulled out of the patient's arm, and it was pulled out the next day after hot compress one night. The puncture site was in the head of the child. After pulling out, the naked eye could see abnormal short catheter. ".
 
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 RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12845194
MDR Text Key285397080
Report Number3014704491-2021-00282
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383033
Device Lot Number1111408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-