MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE-N AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 381511

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

Peripheral iv access was attempted on a neonate unsuccessfully.There was no difficulty with ability to puncture skin and obtain vein access but catheter would not advance further into the vein.Catheter resists/sticks and tracks the skin, refusing to thread.Attempted with multiple lots.Lot# 8059638, 8107753, 8100635, 6363889, 6197861, and 8107753.

• Brand Name: BD INSYTE-N AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 south state street; sandy, ut UT 84070
• MDR Report Key: 7977020
• MDR Text Key: 124094768
• Report Number: 7977020
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381511
• Device Catalogue Number: 381511
• Device Lot Number: 8107753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1