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

Model Number 381433

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

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¿ shielded iv catheter separated from the hub.This was discovered during use.The following information was provided by the initial reporter: material no.: 381433, batch no.: 9238868.It was reported that the iv separated from the hub which was found to still be in the patient's hand and caused bleeding.Iv was inserted into patients vein on left hand.Patient reports iv getting caught when she was reaching for something in her bag.When the nurse came in the iv was bleeding, dressing was saturated, and the iv catheter was no longer on the hub of the iv.After a bedside ultrasound of the hand the catheter was found to still be in the patient's hand.The patient need to have the catheter removed by a vascular surgeon.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter separated from the hub.This was discovered during use.The following information was provided by the initial reporter: material no.: 381433, batch no.: 9238868.It was reported that the iv separated from the hub which was found to still be in the patient's hand and caused bleeding.Iv was inserted into patients vein on left hand.Patient reports iv getting caught when she was reaching for something in her bag.When the nurse came in the iv was bleeding, dressing was saturated, and the iv catheter was no longer on the hub of the iv.After a bedside ultrasound of the hand the catheter was found to still be in the patient's hand.The patient need to have the catheter removed by a vascular surgeon.

Manufacturer Narrative

H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one 20ga insyte autoguard catheter-adapter assembly along with a miscellaneous extension tubing.Through the visual examination the unit was received with the catheter tubing cut off and only 1.5mm (approximately) of tubing (from the nose of the adapter) was visible.The edge of the tubing displayed evidence of stress and stretch.The reported issue was confirmed.Per the verbatim in the reported issue stated as ¿patient reports iv getting caught when she was reaching for something in her bag¿, it can be concluded that the signs of stress observed on the edges of the tubing were likely due to the misuse by the user.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 9545219
• MDR Text Key: 179466907
• Report Number: 1710034-2019-01380
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814337
• UDI-Public: 30382903814337
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

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?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 381433
• Device Catalogue Number: 381433
• Device Lot Number: 9238868
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 72