MAUDE Adverse Event Report: ULRICH MEDICAL USA, INC. ULRICH POWER INJECTOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Lot Number M0190501

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Event Description

Emergency room ct ulrich power injector 24hour internal pump tubing ruptured/leaked, no harm to patient. Fda safety report id #: (b)(4).

• Brand Name: ULRICH POWER INJECTOR
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): ULRICH MEDICAL USA, INC.
• MDR Report Key: 10104976
• MDR Text Key: 194045575
• Report Number: MW5094761
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: M0190501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/29/2020 Patient Sequence Number: 1