MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO CHEMO-AIDE DISPENSING PIN; SET, I.V. FLUID TRANSFER

Catalog Number	2N9106
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two actual samples were returned for evaluation.The returned units were labeled for single use.A visual inspection was performed on the returned units and it was noted that blue particulate matter was observed when uncapping the luer lock cap from the chemo pin spike inside the fluid path and on the snug fit area.The reported problem was verified.The cause of the condition could not be determined.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.
Event or Problem Description
This report summarizes 2 malfunction events.It was reported that particulate matter (pm) was observed in the fluid path of two (2) chemo-aide dispensing pins.The pm was further described as blue residue and was discovered prior to patient use of the device.In both events, there was no patient involvement.No additional information is available.

• Brand Name: CHEMO-AIDE DISPENSING PIN
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8547268
• Report Number: 1416980-2019-02232
• Device Sequence Number: 13543361
• Product Code: LHI
• UDI-Device Identifier: 00085412035130
• UDI-Public: (01)00085412035130
• Combination Product (Y/N): N
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 2N9106
• Device Lot Number: UR18F29048
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1