MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3326
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three potential lot numbers were reported: ur18c14021, ur18f17068, and ur17g22026.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient being treated with an interlink t-connector extension set experienced a disconnection of the set resulting in a "blood spill on the bedside".The cause of the disconnection was not reported.The amount of blood loss was not reported.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Upon follow up it was reported the disconnection occurred between the male luer of the interlink extension set and the patient¿s intravenous (iv) catheter (non-baxter product).The disconnection occurred during an infusion of dextrose 10% with an infusion pump (non-baxter product).It was reported the blood loss was less than 500 ml.No medical intervention was reported for the blood loss.The customer resolved the event by reconnecting the iv set up.It was reported the patient was in stable condition.The clinicians were retrained on the use of the product and no further disconnection issues have occurred at the facility.Batch review were conducted for the three potential lot numbers and there were no deviations found related to this reported condition during the manufacture of these lots.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.
Additional Manufacturer Narrative
The actual device was not available; however, two (2) companion sample were received from code (b)(4), lot numbers: ur18f17068 and ur18c14021.The samples were received in sealed blister packs and no visual defects were observed.Functional test, clear passage and pressure test were performed with no issues.The reported problem was not verified.However, it was reported that the disconnection was between the male luer of the interlink extension set and a non-baxter (jelco iv) catheter.Per the product instructions for use label specification the use of interlink cannula is to be used to access the injection site, not the mentioned jelko iv catheter.A batch review was performed no nonconformance was identified in the batch records.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 7881158
• Report Number: 1416980-2018-05955
• Device Sequence Number: 11384915
• Product Code: FPA
• UDI-Device Identifier: 00085412004648
• UDI-Public: (01)00085412004648
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060074
• 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,Followup
• Report Date (Section B): 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2023
• Device Catalogue Number: 2N3326
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 10/19/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/12/2018; 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other