MAUDE Adverse Event Report: AMSINO INTERNATIONAL INC. AMSINO IV EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number AE3108

Device Problem Burst Container or Vessel (1074)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Event Description

During standard cta stroke imaging, an extension iv set exploded delaying a diagnosis and delaying the opportunity for a mechanical thrombectomy procedure.Diagnosis or reason for use: iv access.

• Brand Name: AMSINO IV EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): AMSINO INTERNATIONAL INC. ; pomona CA 91768
• MDR Report Key: 8222451
• MDR Text Key: 132430996
• Report Number: MW5082884
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/02/2019

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 Model Number: AE3108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 86 YR
• Patient Weight: 68