MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C5641
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
This event occurred during an unspecified date in (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulate matter was observed during use of an extension set.The particulate matter was noted in a ¿cryobag¿ (non-baxter product) attached to the set.This was identified in the final product prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The actual device or photograph of the device was not available; however, a photograph of the particulate matter inside the non-baxter bag was provided for evaluation.Visual inspection of the photograph revealed particulate inside the non-baxter bag identified as "woody plant-like" material.There are no sources of this type of particulate ¿woody plant-like¿ in the manufacturing process for the device.The reported condition could not be verified for the device.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: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8652285
• Report Number: 1416980-2019-02952
• Device Sequence Number: 2039437
• Product Code: FPA
• UDI-Device Identifier: 00085412003818
• UDI-Public: (01)00085412003818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 2C5641
• Device Lot Number: UR18H23088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1