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

Catalog Number 381437

Device Problem Retraction Problem (1536)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter: needle safety did not work did the event involve an urgent/life threatening medical situation? no describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.None reported.

Manufacturer Narrative

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

Event Description

Did the event involve an urgent/life threatening medical situation? no.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.None reported.Please confirm the number of occurrence.2.

Manufacturer Narrative

Investigation results: the complaint that the needle safety did not work was confirmed from the photograph that was provided for investigation.The photo showed an insyte autoguard needle and shield with evidence of use.The needle remained fully extended from the grip.Without the physical sample, the root cause of the damage could not be determined.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• 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: 18970875
• MDR Text Key: 338589156
• Report Number: 1710034-2024-00228
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814374
• UDI-Public: (01)00382903814374
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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 Catalogue Number: 381437
• Device Lot Number: 3124026
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1