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

Catalog Number	2C6700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink blood set filter broke off during patient use.There was no report of a leak.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
A partial device was received for evaluation.The tubing and male luer were received and the blood filter was missing.The male luer was functionally tested with no issues noted.The returned segment of the device was under-water tested for leaks and no issues were noted.Further testing could not be performed as the filter was not returned for evaluation.The reported condition of a broken off filter could not be further evaluated.The reported issue could neither be verified nor refuted from the sample received.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: INTERLINK BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7441451
• Report Number: 1416980-2018-02247
• Device Sequence Number: 11118251
• Product Code: BRZ
• UDI-Device Identifier: 00085412068152
• UDI-Public: (01)00085412068152
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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 Expiration Date: 01/16/2023
• Device Catalogue Number: 2C6700
• Device Lot Number: R18A16095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1