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

Catalog Number	2N3349
Medical Device Problem Codes	Break (1069); 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 six (6) non-dehp high flow rate extension sets leaked during patient use.It was further reported that two (2) of the six (6) sets "broke completely off from the connection sight".The other four (4) leaks were not further specified.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : two (2) actual devices and one (1) companion sample were received for evaluation.Visual inspection of the devices identified 1 actual device where the tubing and luer lock were separated; no issues found during visual inspection of the second actual device or companion sample.Functional testing including clear passage and pressure tests were performed which revealed a leak on 1 actual sample between the tubing and luer lock; no issues were identified on the companion sample.Functional testing was not performed on 1 actual device due to the condition of the sample received.Dimensional testing was performed which revealed 2 actual samples were below the minimum established specification.The reported condition was verified on the 2 actual samples.The cause of the condition was due to human production during manufacturing.The reported condition was not verified on the companion sample.The remaining actual samples were not received; therefore, a device analysis could not be completed on those samples.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: 8861592
• Report Number: 1416980-2019-04286
• Device Sequence Number: 617514
• Product Code: FPA
• UDI-Device Identifier: 00085412004839
• UDI-Public: (01)00085412004839
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/04/2019

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: Health Professional
• Device Catalogue Number: 2N3349
• Device Lot Number: UR18H14079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS