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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 11/27/2019
Event Type  Injury  
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.
 
Event Description
It was reported that the pediatric patient suffered from "venous thrombosis" and "thrombosis with onset of extension to the deep venous network of the arm" during use after the bd insyte¿ autoguard¿ bc shielded iv catheter had been placed.A "simple peripheral kt, polyionic infusion or closed catheter" was used to administer antibiotics to the patient as a result.The following information was provided by the initial reporter: "we are indeed very concerned about this series of 3 patients with venous thromboses on serial and close catheters whereas we do not normally see thromboses of this type in pediatrics." "the three problems encountered were superficial venous thromboses in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thromboses that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.".
 
Event Description
It was reported that the pediatric patient suffered from "venous thrombosis" and "thrombosis with onset of extension to the deep venous network of the arm" during use after the bd insyte¿ autoguard¿ bc shielded iv catheter had been placed.A "simple peripheral kt, polyionic infusion or closed catheter" was used to administer antibiotics to the patient as a result.The following information was provided by the initial reporter: "we are indeed very concerned about this series of 3 patients with venous thromboses on serial and close catheters whereas we do not normally see thromboses of this type in pediatrics." "the three problems encountered were superficial venous thromboses in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thromboses that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.".
 
Manufacturer Narrative
Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key9457851
MDR Text Key179466509
Report Number1710034-2019-01327
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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