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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER

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INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383057
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 08/13/2021
Event Type  Injury  
Manufacturer Narrative
Investigation summary: in response to the event reported, a device history review was conducted for lot number 0267314. 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 nurse pricked their middle finger on the used intima-ii 20gax1. 16in prn slm npvc needle while performing a contrast-enhanced ultrasound. The wound was rinsed under water for a minute before being disinfected with iodophor. The following information was provided by the initial reporter, translated from chinese to english: "at around 18:30 p. M. On (b)(6) 2021, while performing contrast-enhanced ultrasound to help diagnose the nature of breast mass in an outpatient, the nurse pricked the middle finger of her right hand with an indwelling needle that had been used by the patient, causing local bleeding. The wound was quickly drained of blood and rinsed with running water. After rinsing for about a minute, it was locally disinfected with iodophor. After the treatment of the wound, disposable gloves were worn to continue to clean the medical waste after the imaging operation. ".
 
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Brand NameINTIMA-II 20GAX1.16IN PRN SLM NPVC
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12508769
MDR Text Key272567785
Report Number3014704491-2021-00150
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 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number383057
Device Lot Number0267314
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/21/2021 Patient Sequence Number: 1
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