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

Catalog Number 381411

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 during use of the bd insyte-n¿ autoguard¿ shielded iv catheters the catheter sheared off in the patient and required a surgical intervention to be removed.

Event Description

It was reported that during use of the bd insyte-n¿ autoguard¿ shielded iv catheters the catheter sheared off in the patient and required a surgical intervention to be removed.

Manufacturer Narrative

A dhr was performed and all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.There were no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the reported defects stated in the pir.The reported defects were not identified or confirmed and a definite root cause could not be established as no units were provided for this incident.Without the actual sample(s) for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues that would contribute to the alleged defects, as stated in the pir.

• 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: 8241669
• MDR Text Key: 132862320
• Report Number: 1710034-2018-00985
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814115
• UDI-Public: 30382903814115
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 381411
• Device Lot Number: 8206774
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention