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

Catalog Number 381923

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/12/2020

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.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to the customer's report, the catheter was separated from the catheter hub.".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-12-21.Investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one retracted needle assembly, one blue adapter, and one catheter wedge assembly.During the visual examination, it was identified that the wedge and catheter have backed out of the blue adapter which is considered a catheter wedge backout.The reported defect was confirmed.A microscopic inspection of the blue adapter was performed to identify if swage marks were present.Microscopic inspection revealed that no swage marks are present indicating that an improper swage occurred.This defect has been linked to the manufacturing process and corrective actions have been initiated to address the issue.A 100% vision section is in place to detect short flare or incorrect swage depth.Additionally, operators perform sampling per quality procedures for catheter pull tests and retraction.Preventative maintenance is also performed to ensure proper function and upkeep of the equipment.A device history record review could not be performed as the lot number is unknown.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the catheter was separated from the catheter hub.".

• 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: 12940717
• MDR Text Key: 285701331
• Report Number: 1710034-2021-01032
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381923
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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