Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38181114
Device Problem Delivered as Unsterile Product (1421)
Patient Problem Pain (1994)
Event Date 03/11/2022
Event Type  malfunction  
Event Description
It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter backed out of the patient's vein.The following information was provided by the initial reporter, translated from portuguese: "the silicone comes out of place, sometimes before injecting the patient and other times after the puncture of the vein," "neonatal 24 catheter is defective when taking the silicone that protects the needle out of the package.I talked to nurses from the pediatric sector to better understand the problem and they had reported that the silicone that will remain in the vein after the catheter is removed moves before or during the puncture, leading to this difficulty in using the product and requiring adjustment.To the correct location".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record could not be performed as the lot number was unknown.H3 other text : see h.10.
 
Event Description
It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter backed out of the patient's vein.The following information was provided by the initial reporter, translated from portuguese: "the silicone comes out of place, sometimes before injecting the patient and other times after the puncture of the vein," "neonatal 24 catheter is defective when taking the silicone that protects the needle out of the package.I talked to nurses from the pediatric sector to better understand the problem and they had reported that the silicone that will remain in the vein after the catheter is removed moves before or during the puncture, leading to this difficulty in using the product and requiring adjustment.To the correct location".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13965434
MDR Text Key288299819
Report Number9610048-2022-00027
Device Sequence Number1
Product Code FOZ
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
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number38181114
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
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 Sequence Number1
-
-