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

Catalog Number	2C6750H
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uf / importer report number: (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 blood tubing spike of an interlink system y-type blood/solution set was dislodged from the blood tubing.This event occurred during preparation and before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was returned for evaluation.A visual inspection was performed using the naked eye and noted the spike adapter was separated from the tubing.A closer inspection showed that there is present of solvent in the bonding.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported problem was confirmed.The cause of the condition could not be determined.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 - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 7582459
• Report Number: 1416980-2018-03503
• Device Sequence Number: 16773034
• Product Code: BRZ
• UDI-Device Identifier: 00085412073583
• UDI-Public: (01)00085412073583
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/12/2018

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: 02/13/2023
• Device Catalogue Number: 2C6750H
• Device Lot Number: DR18B09015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1