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	08/13/2018
Type of Reportable Event	Serious Injury
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 a jelco intravenous (iv) catheter.The disconnection occurred during infusion of dextrose 10 with an alaris pump, which was reportedly programmed to run at a rate of 3 ml/hr.It was reported the blood loss was less than 500 ml.No medical intervention was reported for the blood loss.The patient resolved the event by reconnecting the iv set up.It was reported the patient was in stable condition.The clinicians were retrained and no further disconnection issues have occurred at the facility.A batch review for lot numbers: ur18f17068, ur18c14021 and ur17g22026 was conducted 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 companion samples (in seal blister packs) were received for evaluation (lot numbers: ur18f17068 and ur18c14021).Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, clear passage and under water pressure testing were performed.The companion samples were determined to meet functional performance specification requirements.The reported condition was not verified.A short-simulated therapy was successfully performed.The cause of the condition could not be determined.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: 7881151
• Report Number: 1416980-2018-05956
• Device Sequence Number: 2507702
• 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): 10/23/2018

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; 10/23/2018
• 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