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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER
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BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
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 that the bd intima-ii¿ closed iv catheter system was involved with a dirty needlestick injury.It has not been specified whether medical intervention/testing was administered as a result.The following information was provided by the initial reporter: in the department of neurology, teachers in the hospital reported that it was difficult to puncture and withdraw the needle.When the dealer came to confirm the situation and inspect the product, needle stick injury happened during his own operation the defective product had been applied to patients (it was not clear who was the patient and whether there was an infectious disease), and the distributor needed to deal with the needle stick injury problem.The dealer¿s needle stick injury occurred after the customer¿s reaction to the needle was blunt and demonstrated to the customer that he was accidentally injured by a needle stick during the operation.
 
Manufacturer Narrative
H6: investigation: a device history review was conducted for lot number 1050065.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.
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system was involved with a dirty needlestick injury.It has not been specified whether medical intervention/testing was administered as a result.The following information was provided by the initial reporter: in the department of neurology, teachers in the hospital reported that it was difficult to puncture and withdraw the needle.When the dealer came to confirm the situation and inspect the product, needle stick injury happened during his own operation the defective product had been applied to patients (it was not clear who was the patient and whether there was an infectious disease), and the distributor needed to deal with the needle stick injury problem.The dealer¿s needle stick injury occurred after the customer¿s reaction to the needle was blunt and demonstrated to the customer that he was accidentally injured by a needle stick during the operation.
 
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Brand Name
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR CATHETER
MDR Report Key12392620
MDR Text Key268961314
Report Number3014704491-2021-00109
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,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/05/2024
Device Catalogue Number383083
Device Lot Number1050065
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/31/2021
Supplement Dates Manufacturer Received09/03/2021
Supplement Dates FDA Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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