MAUDE Adverse Event Report: ICU MEDICAL, INC. 14" TRANSFER SET 4 CLAVE, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP, VENTED CAP; STOPCOCK, I.V. SET

Model Number B33973

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Lower 2 ports of 4-port manifold not glued/bonded on, "popped off" during tubing setup note: there has been a reported trend of disconnections of the clave connector from the body of the transfer set.

• Brand Name: 14" TRANSFER SET 4 CLAVE, 2 TRI-CONNECTORS, BACK CHECK VALVE, CLAMP, VENTED CAP
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15592687
• MDR Text Key: 301645582
• Report Number: 15592687
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33973
• Device Catalogue Number: B33973
• Device Lot Number: UNNOWN
• 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: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1