MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101025

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

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 during treatment with a gambro cartridge set, an external blood leak was observed between the venous line connection and the venous fistula.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual device was not available; however a reference picture was provided for evaluation.The visual inspection revealed a detached blue luer collar resulting in a leak.The reported condition was verified.The cause could not be determined.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: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10436693
• MDR Text Key: 204769886
• Report Number: 8030638-2020-00012
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): Y
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Catalogue Number: 101025
• Device Lot Number: 1000249138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR