MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD; NONE REPORTED

Catalog Number 381811

Device Problem Retraction Problem (1536)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte-n autoguard needle will not retract.The following information was provided by the initial reporter: customer advise that they have a defective catheter.The needle will not retract.They do not have pictures but they do have a sample.Button was not depressed.It can be pushed but the needle was stuck and won't retract.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: BD INSYTE-N AUTOGUARD
• Type of Device: NONE REPORTED
• 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: 19192841
• MDR Text Key: 341675540
• Report Number: 1710034-2024-00357
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818112
• UDI-Public: (01)00382903818112
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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: Health Professional
• Device Catalogue Number: 381811
• Device Lot Number: 3262520
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1