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

Catalog Number	2N3339
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink system non-dehp t-connector extension set was leaking from the t-connector at the point where the extension tubing meets the port.The leak was discovered during use.This issue was resolved by exchanging the set for a new one.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation with the tip protector removed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing (clear passage and pressure test) was performed.Clear passage test passed but the pressure test failed.A leak was observed between the tubing and interlink retractable t-connector.An additional leak test was performed and leak was observe between the tubing and interlink retractable t-connector.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.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.
Additional Manufacturer Narrative
The device was received for evaluation with the tip protector removed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, clear passage, and pressure tests were performed.Clear passage test passed but the pressure test failed.A leak was observed between the tubing and interlink retractable t-connector.Functional testing revealed a leak between the tubing and interlink retractable t-connector.The reported condition was verified.The cause of the condition was determined due to the handling process methodology by manufacturing personnel.A nonconformance has been opened to address this issue.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 SYSTEM T-CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 7922354
• Report Number: 1416980-2018-06216
• Device Sequence Number: 16528861
• Product Code: FPA
• UDI-Device Identifier: 00085412004747
• UDI-Public: (01)00085412004747
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K921899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2018

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: 06/05/2023
• Device Catalogue Number: 2N3339
• Device Lot Number: UR18F05022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 11/02/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1