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

Catalog Number 381434

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard plastic inside the hub opening.The following information was provided by the initial reporter: i am sending this message to notify bd that we discovered a defect in one of your iv catheters today (3/4/2024) at our facility.The opening of the iv catheter hub (where the iv bag line is connected) had a small plastic piece sticking out from the side (inside the hub by opening).The plastic piece was the same color as the hub.This was noted when the nurse attempted to hook up the iv line to the hub (the plastic piece prevented the line connecter from going into the catheter hub).As a result, the successfully inserted catheter had to be removed from the patient¿s arm and restarted in another location.Please note that the patient was not harmed ¿ however, they did have to be poked twice as we needed to restart the iv elsewhere.The nurse was unharmed as well.The patient¿s procedure was delayed by approximately 10 minutes while we restarted the iv in a different location.Please feel free to reach out to me with any additional questions.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: a device history record review was completed by our quality engineer team for provided material number 381434 and lot number 3277682.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Complaints received for this device and reported condition will continue to be tracked and trended.

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: 18986260
• MDR Text Key: 339672927
• Report Number: 1710034-2024-00244
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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: 381434
• Device Lot Number: 3277682
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1