MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 11/24/2019

Event Type  Injury  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8331651, medical device expiration date: 2021-11-30, device manufacture date: 2018-11-27.Medical device lot #: 9127879, medical device expiration date: 2022-04-30, device manufacture date: 2019-05-07.Medical device lot #: 8214631, medical device expiration date: 2021-07-31, device manufacture date: 2018-08-10.Medical device lot #: 8214630, medical device expiration date: 2021-07-31, device manufacture date: 2018-08-10.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 thrombosis occurred during use with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, "small superficial venous thrombosis on ktp (poriferous catheter) obstruction.Ktp for atb not increased.Lovenox 4000 vi not nursing 10 days." information received on december 2: hello, 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 batch numbers are those noted for the last patient of 24 november.I do not know the lot numbers of the 2 previous statements.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

H.6 investigation summary: the photos provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of these batches.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

Event Description

It was reported that thrombosis occurred during use with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter: "small superficial venous thrombosis on ktp (periferous catheter) obstruction.Ktp for atb not increased.Lovenox 4000 vi not nursing 10 days.Information received on december 2: hello, 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 batch numbers are those noted for the last patient of (b)(6).I do not know the lot numbers of the 2 previous statements.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.".

• 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 Key: 9474253
• MDR Text Key: 179466727
• Report Number: 1710034-2019-01333
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 381023
• Device Lot Number: SEE. H.10
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other