MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"; INTRAVASCULAR CATHETER

Model Number 381434

Device Problem Defective Device (2588)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte autoguard straight, 20g x 1.16" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter: we have had multiple catheters, all from lot#: 2160587, that do not retract the needle when the button is pressed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 30jan2023.H6: investigation summary: bd received ten sealed 20 gauge insyte autoguard units from lot 2160587 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no visible damage or deformities to the units or their components.Next, the units were tested for functional retraction and each unit retracted successfully with no resistance or delay observed.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during inspection a definitive root cause could not be determined.However, a trend has been identified for this failure mode and an investigation has been launched by the manufacturing facility to correct this issue.The manufacturing facility has been notified of this incident and the findings.

Event Description

It was reported while using bd insyte autoguard straight, 20g x 1.16" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter: we have had multiple catheters, all from lot #2160587, that do not retract the needle when the button is pressed.

• Brand Name: BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301608
• MDR Text Key: 308826086
• Report Number: 1710034-2023-00069
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381434
• Device Catalogue Number: 381434
• Device Lot Number: 2160587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• 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