MAUDE Adverse Event Report: ICU MEDICAL, INC LIFESHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1141505

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The nurse went to discard the old tpn (total parenteral nutrition), tubing, and extension set to replace it with new tpn, tubing, and extension set.On an attempt to remove the extension set from the cvc lumen, the secure lock male adapter was unscrewed upon pulling back it would not dislodge from the cvc lumen.Multiple attempts were made to remove the line with no success.On the last attempt, the tip of the adaptor broke off in the purple lumen.

• Brand Name: LIFESHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 14353611
• MDR Text Key: 291384040
• Report Number: 14353611
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1141505
• Device Catalogue Number: 1141505
• Device Lot Number: 5634863
• 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: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1