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

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU INTIMA-II Y 24GAX0.75IN PRN/EC SLM 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
 

BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported a device history review was conducted for the provided lot number. Our records show that this is the only instance of this issue occurring in this production batch. According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections. A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications. Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. Bd will continue to monitor this issue.
 
Event Description
It was reported intima-ii y 24gax0. 75in prn/ec slm had leakage issues. The following information was provided by the initial reporter, translated from chinese: "the patient was given intravenous puncture infusion with indwelling needle. And it was found that the prn had leakage during infusion after successful puncture".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTIMA-II Y 24GAX0.75IN PRN/EC SLM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
MDR Report Key12442962
MDR Text Key283317834
Report Number3014704491-2021-00128
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383033
Device Lot Number1051519
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-