MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTERLINK BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C7564
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink buretrol solution set was blocked.This occurred before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and the device was unable to prime as no flow was observed through the line.A blockage was noted in the drip chamber of the device.During a filter integrity test, it was observed that the disc was not filling with air when pressure was applied.When the filter was cut, a blockage with flashing or solvent was observed.The subassembly center hole was too small to allow liquid flow.The reported condition was verified.The cause of the reported condition was determined to be a manufacturing issue.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 BURETROL SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 7566620
• Report Number: 1416980-2018-03377
• Device Sequence Number: 11351552
• Product Code: FPA
• UDI-Device Identifier: 00085412002781
• UDI-Public: (01)00085412002781
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

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: 2C7564
• Device Lot Number: DR18B13017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1