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

Catalog Number 2N3326

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

The patient's age was reported as a neonate.Weight: (b)(6) grams.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during use with an interlink t-connector extension set, a disconnection occurred ¿from the hub of the iv catheter¿ which resulted in blood leak.The cause of the disconnection was not reported.It was reported an approximate blood loss of ¿five to six ml¿ occurred.It was reported a transfusion was needed (no further details provided).At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection of the companion sample did not identify any abnormalities that could have contributed to the reported condition.Functional, pressure and clear passage testing were performed and passed.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.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: a3, b5, b7, e4, g3, h10.B5: upon follow up it was reported blood was observed on the arm board and sheets.The nurse unwrapped the dressing to find that t-connector was dislodged from catheter.It was reported the nurse reconnected and redressed the left radial peripheral ¿a-line¿.It was reported the arterial line was taped and the t-connector was taped securely.It was reported approximately 5ml of blood was lost and packed red cells were given.F2 - the customer reported this event to the fda through medwatch 1000060000-2020-8016.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM T-CONNECTOR EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9457173
• MDR Text Key: 170425567
• Report Number: 1416980-2019-06849
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004648
• UDI-Public: (01)00085412004648
• Combination Product (y/n): N
• PMA/PMN Number: K060074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2024
• Device Catalogue Number: 2N3326
• Device Lot Number: UR19F10039
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/07/2020; 05/01/2020
• Supplement Dates FDA Received: 01/10/2020; 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention