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

Catalog Number JC7751

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the luer lock of a y-type blood solution set was unable to connect to an iv cannula hub.The luer lock was 'stuck'.This occurred during patient connection.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The sample was received for evaluation.A visual inspection was performed and it was observed that the component was stuck and could not be rotated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause was not 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: 6888637
• MDR Text Key: 87517046
• Report Number: 1416980-2017-07779
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: JC7751
• Device Lot Number: DR17C10046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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