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

Catalog Number	2C5641
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 an extension set was cracked which resulted in a leak.During filling, it was discovered that the female extension set connected to the male stopcock assembly was cracked which caused a leak.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : device manufacturing date: the device was manufactured on an unspecified date in october 2016.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.

• Brand Name: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8680499
• Report Number: 1416980-2019-03147
• Device Sequence Number: 1808129
• Product Code: FPA
• UDI-Device Identifier: 00085412003818
• UDI-Public: (01)00085412003818
• Combination Product (Y/N): N
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: UR16I22064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1