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

Catalog Number	2C8862
Medical Device Problem Codes	Fluid/Blood Leak (1250); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on an unspecified date in (b)(6) 2019.(b)(6).The customer reported this event to the fda through medwatch uf/importer report #: (b)(4).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 discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink buretrol solution set ¿filled despite the valve being clamped.It then started leaking out the top of the buretrol chamber while it was hanging on an iv (intravenous) pole.The iv was never hooked to a patient.¿ this was identified while priming the buretrol tubing with normal saline.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK BURETROL SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8880148
• Report Number: 1416980-2019-04355
• Device Sequence Number: 2028765
• Product Code: FPA
• UDI-Device Identifier: 00085412073354
• UDI-Public: (01)00085412073354
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: 2C8862
• Device Lot Number: DR19A17019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1