MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number 381834

Device Problem Retraction Problem (1536)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the needle and shield from an insyte autoguard device.The catheter was not present on the needle.The needle appeared to be fully extended and no bends or damage were observed on the device.As the video played, it appeared that multiple attempts were made to activate the safety mechanism, but no movement of the needle could be observed.This report appeared to be likely manufacturing-related; however, without the physical sample, it could not be determined if the cause was related to excess adhesive, a bound spring, or other root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

Event Description

It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter, translated from chinese to english: no product.(b)(6) 2024: let me clarify the pir issue is safety mechanism can¿t be activated.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19197262
• MDR Text Key: 341540905
• Report Number: 1710034-2024-00365
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381834
• Device Lot Number: 2250399
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1