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

Catalog Number	2N3374
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
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 a leak was discovered between the connection of an interlink system catheter extension set and a non-baxter refill kit.The leak was observed during administration of intrathecal injection to a patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : the device was received for evaluation.The sample was incomplete with missing interlink.Visual inspection was performed on the returned sample, no defects were observed.Functional tests including clear passage and pressure test were performed and the results were satisfactory.The reported condition was not verified.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: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8237119
• Report Number: 1416980-2018-08264
• Device Sequence Number: 11198813
• Product Code: FPA
• UDI-Device Identifier: 00085412004907
• UDI-Public: (01)00085412004907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 12/10/2021
• Device Catalogue Number: 2N3374
• Device Lot Number: UR16L10031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/11/2019
• 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: GABALON INTRATHECAL INJECTION 0.2%; MEDTRONIC REFILL KIT