MAUDE Adverse Event Report: ICU MEDICAL, INC UNKNOW; CARDIAC CATHETERIZATION KIT

Catalog Number 46096-26

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Event Description

The burette in the manifold kit has a hole in it.A new kit was opened and dropped.Cath lab kit.The hole was noticed before the case started and no harm was done to the patient.

• Brand Name: UNKNOW
• Type of Device: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 5856343
• MDR Text Key: 51497509
• Report Number: 5856343
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 46096-26
• Device Lot Number: 3245752
• Other Device ID Number: CONTRAST BURETTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR