MAUDE Adverse Event Report: ICU MEDICAL, INC. 154" 15 DROP PRIMARY SET W/4 MICROCLAVE; STOPCOCK, I.V. SET

Model Number B33920

Device Problems Crack (1135); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

There was a crack in the iv tubing allowing medication and fluid to leak out.The patient did not respond to sedation medication, and upon further inspection the iv tubing leak was found.It was not due to loose connections, but an actual crack in the hard part of the tubing.

• Brand Name: 154" 15 DROP PRIMARY SET W/4 MICROCLAVE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 12421407
• MDR Text Key: 269792519
• Report Number: 12421407
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021,08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33920
• Device Catalogue Number: B33920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1