MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10; INTRAVASCULAR CATHETER

Catalog Number 381023

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

Patient Problem Thrombosis (2100)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1.00in.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 an unspecified number of bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology 22ga 1.00in were involved with patient's experiencing thrombosis during use.Three patients experienced superficial venous thrombosis after catheterization.It has not been specified whether any medical intervention was sought or received as a result of the thrombosis.The following information was provided by the initial reporter: small superficial venous thrombosis on ktp (peripherous catheter).We are indeed very concerned about this series of 3 patients with venous thrombosis on serial and close catheters whereas we do not normally see thrombosis of this type in pediatrics.I do not know the lot numbers of the previous statements.The three problems encountered were superficial venous thrombosis in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thrombosis that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.

Manufacturer Narrative

Type of reportable events: serious injury.Investigation summary: 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.

Event Description

It was reported that an unspecified number of bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology 22ga 1.00in were involved with patient's experiencing thrombosis during use.Three patients experienced superficial venous thrombosis after catheterization.It has not been specified whether any medical intervention was sought or received as a result of the thrombosis.The following information was provided by the initial reporter: small superficial venous thrombosis on ktp (peripherous catheter) we are indeed very concerned about this series of 3 patients with venous thrombosis on serial and close catheters whereas we do not normally see thrombosis of this type in pediatrics.I do not know the lot numbers of the previous statements.The three problems encountered were superficial venous thrombosis in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thrombosis that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.

• Brand Name: SEE H.10
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9459112
• MDR Text Key: 178330142
• Report Number: 1710034-2019-01329
• 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: 12/30/2019

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 381023
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other