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

Catalog Number FNC1166

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that one (1) blood/solution infusion set w/ clearlink and hand pump disconnected; the tip of the giving set had come away from the remainder of the tubing on priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: three devices; not one device, were reported to have disconnected.Date returned to mfr - one device was returned on 10/18/2018 and the other two were returned on 10/22/2018.Three devices were received for evaluation.During visual inspection, the tubing was observed separated from the 2-piece luer locks in the samples.There are trace of solvent at tubing end where separation observed.All samples were tested with 8psi under water pressure test and no leaks were observed.The reported condition was verified.The cause was due to a machine in the manufacturing process.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: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7970679
• MDR Text Key: 124364407
• Report Number: 1416980-2018-06583
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412068817
• UDI-Public: (01)00085412068817
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: FNC1166
• Device Lot Number: SR18F12033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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