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

Catalog Number	2N3326
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9457173
• Report Number: 1416980-2019-06849
• Device Sequence Number: 19606601
• Product Code: FPA
• UDI-Device Identifier: 00085412004648
• UDI-Public: (01)00085412004648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2024
• Device Catalogue Number: 2N3326
• Device Lot Number: UR19F10039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 05/01/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/10/2020; 05/04/2020
• 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: Required Intervention