MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 2C6700

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted medwatch 0700070000-2022-8025 for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an interlink straight type blood set would not connect to a bag of platelets.This issue was further described as, ¿connector on end of tubing would not connect to male adapter plug, or any other port on any another tubing tried¿.This issue was identified during priming.To resolve this issue, a new set was used and work appropriately.There was no patient involvement.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15802589
• MDR Text Key: 307320814
• Report Number: 1416980-2022-06247
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412068152
• UDI-Public: (01)00085412068152
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C6700
• Device Lot Number: R22D06048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.