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

Catalog Number 381034

Device Problem Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical 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.(b)(4).

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter hub would not connect to the infusion line.The following information was provided by the initial reporter, translated from (b)(6) to english: "after catheter placement, the hcp attempted to connect the catheter hub to the infusion line and could not connect.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received three photographs and one unit.The photographs displayed similarities to that of the returned unit.The unit received was a used 20ga bd insyte autoguard blood control iv catheter unit.Upon visual observation it is observed that there is slight damage to the bottom of the threads opposite each other.There is no damage to the end of the adapter or outer threads.This damage to the outer threads of the luer could prevent a connection to be achieved as described in your report.The reported issue was confirmed.Damage to the outside of the adapter could occur anywhere where an adapter luer encounters equipment due to gripper misalignments relative to the adapter.Alignments are performed when they are determined to be necessary during set up or production.A connection between a laboratory bd q-syte unit and the end of the luer adapter demonstrated inability to secure a connection, therefore further confirming connection issues.Dhr could not be performed due to unknown lot#.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter hub would not connect to the infusion line.The following information was provided by the initial reporter, translated from japanese to english: "after catheter placement, the hcp attempted to connect the catheter hub to the infusion line and could not connect.".

• Brand Name: BD INSYTE AUTOGUARD BC 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: 11182462
• MDR Text Key: 227764599
• Report Number: 1710034-2021-00038
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1