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

Model Number 381823

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

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 bd insyte¿ autoguard¿ shielded iv catheter had foreign matter.The following information was provided by the initial reporter, translated from (b)(6): "when i opened the cap to puncture and looked at the tip, there was a deposit, so i stopped using it.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-11-24.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one opened retracted unit for investigation.In addition, five photos were also received for investigation.Upon inspection of the received unit and the photos it was identified that foreign matter is present on the inside of the needle cover.No foreign matter was observed on the needle.The foreign matter was found to be a clear, flexible solid and has a rough surface.Based on the foreign matter being stuck to the inside of the needle cover, the foreign matter can most likely be attributed to the manufacturing or molding process.This type of defect may be caused by multiple factors including environmental factors, incoming material, personnel, and processing (e.G., machine component wear).A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported bd insyte¿ autoguard¿ shielded iv catheter had foreign matter.The following information was provided by the initial reporter, translated from japanese: "when i opened the cap to puncture and looked at the tip, there was a deposit, so i stopped using it.".

• Brand Name: BD INSYTE¿ 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12898741
• MDR Text Key: 285805477
• Report Number: 1710034-2021-01022
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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 Expiration Date: 01/31/2024
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 1053241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1