MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INTROSYTE-N; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT TERM

Model Number AUTOGUARD 26 GA

Device Problems Positioning Failure (1158); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

Infant patient: in attempting to start a picc line on infant, introducer was inserted and received blood return.Retracted introducer needle, leaving the introducer catheter only.Nurse attempted to thread the picc line through the introducer and could not after multiple attempts.Removed introducer and picc line.Once this was out of patient they tried to thread the picc through the introducer again and were still unable to do so while being observed by 2 two other physicians and a nurse.Nurse pulled apart the introducer (as they are designed to do) to check for a clot or occlusion and could not see any obstruction.In attempting another picc before inserting the introducer into the skin they removed the needle from the introducer first and slid the picc through the catheter to check that it was clear and were able to (although it was a different lot # of introducer).Nurse was unable to hit a vein properly with this introducer so they tried again with another.Nurse attempted another picc and again could not get the picc line to advance through the introducer (although not sure the introducer was in the vein properly in order to start the picc).Again pulled the picc line out of the introducer and tried to advance the picc into the introducer.The picc line would, again, not advance through the introducer.This introducer was left intact this time for further evaluation.They did remove another introducer from the supply cabinet to check the lot and the picc would advance through that introducer.

• Brand Name: BD INTROSYTE-N
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.; 9450 s state st; sandy UT 84070
• MDR Report Key: 3896620
• MDR Text Key: 4676009
• Report Number: 3896620
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/11/2014

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: Nurse
• Device Model Number: AUTOGUARD 26 GA
• Device Catalogue Number: 384008
• Device Lot Number: 3274991
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 5