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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 20GA X 1.16IN CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 20GA X 1.16IN CATHETER Back to Search Results
Catalog Number 38831414
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Phlebitis (2004); Insufficient Information (4580)
Event Date 06/28/2021
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that insyte 20ga x 1. 16in. The following information was provided by the initial reporter: the patient entered the clinic for an outpatient colonoscopy procedure on (b)(6) and an iag 20g was inserted into the back of the right hand, no more than 2 hours elapsed, since it was a short ambulatory procedure. They removed the immobilization adhesives from the peripheral catheter iag 20g on the back of the right hand and then the patient arrives consulting because the vein is inflamed, they performed ultrasound and report that a tubular image of hyperechoic walls with 30mm length is observed, they reconfirm with doppler and refer endoluminal foreign body. Presence of the catheter within the patient's vein, pending assessment by a vascular surgeon on thursday, (b)(6). Additional information received on 07/30/2021: there is no batch information, the catheter did not break, the propofol drug was being used, the catheter was not occluded at any time, we checked the patency of the catheter with saline solution. The catheter was discarded. There was no need to remove any catheter fragments from the patient.
 
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Brand NameINSYTE 20GA X 1.16IN
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key12310716
MDR Text Key266147717
Report Number9610048-2021-00113
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number38831414
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
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

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1
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