MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. CLEARLINK SYSTEM Y-TYPE BLOOD TRANSFUSION SET; SET, BLOOD TRANSFUSION

Catalog Number 2C8750S

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2016

Event Type  malfunction  

Event Description

Rn was attempting to administer blood and observed there to be a hole in the blood tubing, luckily this was before spiking the blood bag.Defect was found before product was used on the patient.Manufacturer response for y-type blood/solution set with standard blood filter, clearlink system (per site reporter): they sent me shipping material.

• Brand Name: CLEARLINK SYSTEM Y-TYPE BLOOD TRANSFUSION SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.; 911 north davis; cleveland MS 38732
• MDR Report Key: 6215504
• MDR Text Key: 63637491
• Report Number: 6215504
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2C8750S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO, DEFECT FOUND BEFORE PRODUCT WAS USED WITH PATI
• Patient Age: 36 YR
• Patient Weight: 82