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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Unintended Ejection (1234)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported a device history review was conducted for lot number 0168655. 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. Unfortunately, a sample could not be obtained for evaluation and testing. Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. We check the retained sample from the complained batch and there is no abnormality. Bd will continue to monitor this issue.
 
Event Description
It was reported that bd intima ii¿ iv catheter prn adapter leaked. The following information was provided by the initial reporter: " the indwelling needle fell off and the puncture point was bleeding. ".
 
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Brand NameBD INTIMA II¿ IV CATHETER PRN ADAPTER
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12619226
MDR Text Key282268902
Report Number3014704491-2021-00194
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 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383019
Device Lot Number0168655
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
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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