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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER

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BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2021
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. Unfortunately 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 bd intima-ii y 24gax0. 75in prn/ec slm had ruptured tubing, causing leakage. The following information was provided by the initial reporter, translated from chinese: ". The patient¿s family came to the nurse and said that the indwelling needle was broken and there was bleeding. The nurse checked it in time and found that the extension tube of the indwelling needle was broken and there was bleeding at the break. ".
 
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Brand NameBD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12723977
MDR Text Key279313642
Report Number3014704491-2021-00231
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 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383033
Device Lot Number1050976
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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