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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ CATHETER I.V. 22G X1.00

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ CATHETER I.V. 22G X1.00 Back to Search Results
Model Number 381823
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd insyte¿ autoguard¿ catheter i. V. 22g x1. 00 guide came off the needle. The following information was provided by the initial reporter: when performing a peripheral venipuncture, the catheter guide came off the needle, making it impossible to introduce the catheter into the patient's vein. The button that activates the safety device is poorly located, causing any accidental touch to activate it, making the puncture procedure impossible again. These mentioned factors cause greater risk to the professional of accidents with sharps and also discomfort and anxiety to the patient due to the failure of the procedure. Info added on 19. Oct. 2021: customer reports it means: "the catheter got loose from the needle, making impossible to insert the catheter into the patient's vessel. " there are no pictures available, not videos either. The issues have occurred during puncturing moment, which the catheters couldn't be used have been immediately discarded. It's not possible to know exactly how many units have been affected, once the complaint has been received from health professionals of inpatient sector that use the catheters. Only one single health professional has complimented the catheter and says he is used to use the catheter because he has used it in another facility.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ CATHETER I.V. 22G X1.00
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12776527
MDR Text Key280509132
Report Number9610048-2021-00151
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381823
Device Catalogue Number38182314
Device Lot Number1124353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2021
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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