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

Catalog Number 381434

Device Problem Retraction Problem (1536)

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

Event Date 02/29/2024

Event Type  malfunction  

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

It was reported that bd insyte autoguard needle partially retracted.The following information was provided by the initial reporter: we¿re seeing a pattern with the safety mechanism on the 20ga insyte autoguards not completely covering the end of the sharp after deployment.A couple instances happened at st.Ann¿s earlier this month, and we¿ve seen several more at the grove city campus.

Manufacturer Narrative

Investigation results: the complaint that the needle tip remained exposed after retraction was confirmed from the photograph that was provided for investigation.The photo showed a partially retracted needle with the needle tip extending beyond the opening in the grip.Due to the position of the needle, barrel damage that would preclude full retraction of the needle was a potential contributing factor; however, the barrel was hidden behind the fingers that were holding the device and the root cause of the exposed needle 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.Although the root cause could not be determined, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

Event Description

No additional information.

• 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: 19003329
• MDR Text Key: 338922265
• Report Number: 1710034-2024-00259
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: Other
• Device Catalogue Number: 381434
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1