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

Catalog Number 38101214

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2018

Event Type  Injury  

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 a bd insyte¿ autoguard¿ bc had a catheter tip brake during use.The tip of the catheter was reported to have remained in the vein of the patient.The patient was evaluated by a angiologist.The angiologist performed imaging, but no traces of the catheter were found, and no damage was found.

Event Description

It was reported that a bd insyte autoguard bc had a catheter tip brake during use.The tip of the catheter was reported to have remained in the vein of the patient.The patient was evaluated by a angiologist.The angiologist performed imaging, but no traces of the catheter were found, and no damage was found.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacture: yes.Received a 24ga iag bc catheter-adapter assembly connected to a 5ml bd syringe, no packaging material was received.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of catheter broke / separated after placement with lot #7198629 regarding item 38101214.The sub assembly lot (7031945) was built on afa line 9 on 19aug2017 through 21aug2017 and bulk packaged on 9feb2017 for the quantity of (b)(4).All challenge, set-up and in process samples were performed according to the quality control plan and all passed per specifications.No quality notifications were initiated during production.Observed there was traces of blood residue on the catheter tubing and inside the adapter (wedge/tubing assembly area).Observed there was approximately 11mm of catheter tubing (from the nose of the adapter to the highest point of the tubing) and the catheter tip was missing.The area of separation at the catheter tubing had jagged and rough edges (indication of stress).The area of separation revealed a v shaped cut characteristic and another cut (also v shaped) was also present near the area of separation.It is uncertain whether the defects observed on the catheter tubing were caused by manipulation of the device prior to insertion or by the manufacturing process.The v shaped cuts are supporting evidence the damage was caused by manipulation (re-cannulation) of the device.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7810071
• MDR Text Key: 118041598
• Report Number: 1710034-2018-00579
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 38101214
• Device Lot Number: 7198629
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention