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

Catalog Number	2C6931
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer lock connector of an interlink continu-flo multi-port manifold set ¿falls apart after tightening¿ (disconnects).It was further reported that the luer lock could not be finger tightened and as a result, the ¿luer lock-falls apart even after pushing slip tip in and twisting.¿ this was identified during set-up.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: two (2) samples were received for evaluation.A visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The samples were functionally tested and primed.Additionally, the samples were submitted to pressure and block tests.The samples primed and flowed normally.There were no issues observed.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9673583
• Report Number: 1416980-2020-00435
• Device Sequence Number: 319447
• Product Code: FMG
• UDI-Device Identifier: 00085412035475
• UDI-Public: (01)00085412035475
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/11/2020

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: Other
• Device Catalogue Number: 2C6931
• Device Lot Number: DR18F12036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1