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

Catalog Number	2C6700
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1416980-2022-06247
• Device Sequence Number: 5471390
• Product Code: BRZ
• UDI-Device Identifier: 00085412068152
• UDI-Public: (01)00085412068152
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2C6700
• Device Lot Number: R22D06048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/15/2022
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown