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

Catalog Number JC7751

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported blood recipient set leaked.During priming with normal saline prior to platelet infusion, the saline was observed ¿spraying out of plastic joint just above the blood filter¿.A crack was noted along the white plastic part (also reported as a small break in the iv line).Approximately 10ml had leaked out of the line.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection and functional test were performed and noted a leak around the top cap filter due to a crack in the white side.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 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: 6597797
• MDR Text Key: 76160846
• Report Number: 1416980-2017-04573
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: JC7751
• Device Lot Number: DR16L13092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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