MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD GAUGE 22

Catalog Number REF 381423

Device Problems Break (1069); Physical Resistance (2578)

Patient Problem Pain (1994)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

After the piv locked on the left hand was flushed, the patient complained of pain and the nurse noticed a slight resistance when she tried to remove it.When she tried to pull on it the second time, the piv came out easily but the catheter broke about 1/4 cm below the blue hub.

• Brand Name: BD INSYTE AUTOGUARD GAUGE 22
• Type of Device: BD INSYTE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; sandy UT 84070
• MDR Report Key: 7582090
• MDR Text Key: 110720506
• Report Number: MW5077686
• Device Sequence Number: 0
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: REF 381423
• Device Lot Number: 8002764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1