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

Catalog Number	2C9218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2019
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 slide clamps of two (2) radiation sterilized extension sets ¿were falling off because they were open at one end¿.This was identified at unspecified process steps.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
One device was received for evaluation; however, one device was not returned; therefore, a device analysis could not be completed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and there were no issues noted during clear passage and pressure testing.A dimension inspection was also performed with no issues noted.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: RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8294244
• Report Number: 1416980-2019-00475
• Device Sequence Number: 1734014
• Product Code: FPA
• UDI-Device Identifier: 00085412004259
• UDI-Public: (01)00085412004259
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Expiration Date: 06/18/2023
• Device Catalogue Number: 2C9218
• Device Lot Number: UR18F18140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1