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

Catalog Number	2N3348
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2018
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 the extension set tubing fell apart during set up.This event was further described as the end piece of the microbore tubing falling off.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During visual inspection, the male luer lock adapter was noted to be missing and the luer lock cap was observed loose.Dimensional inspection was performed with satisfactory results.The reported condition was verified.The cause of the event was determined to be related to the manufacturing process.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: MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 7353140
• Report Number: 1416980-2018-01459
• Device Sequence Number: 2024002
• Product Code: FPA
• UDI-Device Identifier: 00085412004822
• UDI-Public: (01)00085412004822
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• 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): 04/18/2018

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: 06/22/2022
• Device Catalogue Number: 2N3348
• Device Lot Number: UR17F22044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1