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

Catalog Number 381511

Device Problems Material Deformation (2976); Suction Failure (4039)

Patient Problem Extravasation (1842)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

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 there was a difficult penetration due to poor catheter tip, as well as flashback with a bd insyte-n¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: it was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.Uvc had to be placed which is more invasive and increased risk for infection.

Event Description

It was reported that there was a difficult penetration due to poor catheter tip, as well as flashback with a bd insyte-n¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: it was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.Uvc had to be placed which is more invasive and increased risk for infection.

Manufacturer Narrative

H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

• Brand Name: BD INSYTE-N¿ 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: 8569029
• MDR Text Key: 143694248
• Report Number: 1710034-2019-00476
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815112
• UDI-Public: 30382903815112
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 381511
• Device Lot Number: 8275532
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other