MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC TRANSFER SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	1C8624
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 1 malfunction events.It was reported that an extension set leaked blood from an unspecified location during infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: TRANSFER SET
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8832627
• Report Number: 1416980-2019-04063
• Device Sequence Number: 2755024
• Product Code: NEP
• UDI-Device Identifier: 00085412031842
• UDI-Public: (01)00085412031842
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 1C8624
• Device Lot Number: DR17I28060
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1