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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 16GA X 1.88IN 1.7 X 48MM INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 16GA X 1.88IN 1.7 X 48MM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38833014
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 angiocath 16ga x 1. 88in 1. 7 x 48mm catheter was found split during the puncture. The following information was provided by the initial reporter, translated from spanish to english: "the bevel is not very sharp, the catheter blooms in most cases it is difficult to puncture, it must be done with a lot of pressure. The side effects produced by abocath angiocath are the following: increase in the number of punctures in the patient, as a good venous access is not achieved, due to what has been described in the quality failure: the catheter blooms, the sear is not very sharp. This also means that the placed via does not last long, subjecting to new punctures to place a new via and complete the indicated treatment. The same patients complain and sometimes refuse a new attempt. When the catheter blooms, it damages the veins, causing them to creep and consequently injure the affected limb (hematoma, swelling). ".
 
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Brand NameANGIOCATH 16GA X 1.88IN 1.7 X 48MM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key12256240
MDR Text Key264464858
Report Number9610048-2021-00107
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 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38833014
Device Lot Number9329909
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2019
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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