MAUDE Adverse Event Report: ICU MEDICAL, INC. 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET; STOPCOCK, I.V. SET

Model Number A1001

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

The small-bore extension set with clamp / rotating luer (j loop) did not connect to the iv properly.The connection is not secure and there is leaking.Reportedly, this occurred twice.

• Brand Name: 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15145578
• MDR Text Key: 297038317
• Report Number: 15145578
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709051027
• UDI-Public: (01)00887709051027
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1001
• Device Lot Number: 5956762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1