MAUDE Adverse Event Report: ICU MEDICAL, INC. CONTRAST MEDIA INJECTION LINE

Model Number 42432-48

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

Medsun report received reporting breakage/leakage issues with use of one 42342-48 48" contrast media inj.Line.The medsun report describes the event as follows ".Contrast media injector connected to medrad.When medrad activated, the device broke at distal connection.Blood and contrast dye was distributed throughout the operating room.Blood was splashed on persons in the operating room, but protective gear was being worn, no skin contact." the mfr.Has made multiple requests for additional information and status of device return.As of the date of this report there has been no response.

• Brand Name: CONTRAST MEDIA INJECTION LINE
• Type of Device: CONTRAST MEDIA INJECTION LINE
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5336876
• MDR Text Key: 34771406
• Report Number: 2025816-2015-00153
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2015

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 Expiration Date: 08/01/2015
• Device Model Number: 42432-48
• Device Catalogue Number: 42432-48
• Device Lot Number: 92-569-YJ
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2015
• Distributor Facility Aware Date: 10/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2015
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 136