MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 2C8750

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a slice in the tubing of an clearlink y-type blood/solution set was observed during setup.The reporter stated that the cut area looked ridged.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Importer report number: (b)(6).(b)(4).The hole in the blood tubing was observed prior to spiking the blood bag.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed a cut in the tubing.The package did not have any obvious cuts, tears, or damage.The reported condition was verified.The cause of the condition was determined to be a human error during manufacturing.Awareness training has been provided to appropriate personnel.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6219873
• MDR Text Key: 63777866
• Report Number: 1416980-2016-18973
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Catalogue Number: 2C8750
• Device Lot Number: DR16G04058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2017; 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1