MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET

Catalog Number	2C6921
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of interlink system 3-port manifolds disconnected.The event was further reported as during a procedure the "tubing was connected to extension set and disconnected despite tightening both ends upon connecting to the patient".The disconnection was observed "on the connection between the manifold and the patient's side".The tubing fell to the floor.The patient was receiving an infusion of unspecified fluids and medications due to patient receiving spinal/epidural.The tubing was changed, and the procedure was completed without further incidents.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was manufactured from february 15, 2017 - march 01, 2017.H10: the actual sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed by locking and unlocking the luer lock with no issues noted.The reported problem 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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK MULTI-PORT MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9387078
• Report Number: 1416980-2019-06617
• Device Sequence Number: 2207743
• Product Code: FMG
• UDI-Device Identifier: 00085412035451
• UDI-Public: (01)00085412035451
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K932512
• 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
• Report Date (Section B): 01/02/2020

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: Health Professional
• Device Catalogue Number: 2C6921
• Device Lot Number: GR337329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUIDS; UNSPECIFIED MEDICATION