MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC.; SET, BLOOD TRANSFUSION

Model Number 2C8570S

Device Problems Break (1069); Crack (1135); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Tubing malfunction.Hub to hub connection for cell infusion.Unable to disconnect easily.Tubing appeared to be stuck in catheter.It took two kelly clamps and assistance from another nurse to finally remove.Tubing appears cracked and broken at the end connection.

• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16102033
• MDR Text Key: 306695384
• Report Number: 16102033
• Device Sequence Number: 1
• Product Code: BRZ
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C8570S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White