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

Catalog Number	2C6931
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This has been occurring ¿over the past three months¿.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer collar that connects to the manifold and the male luer lock of an unspecified number of interlink system continu-flo solution sets would not tighten and ¿falls apart¿.This was further described as, upon removal of the ¿anesthesia iv (intravenous) set from its packaging, the nurse tightens all connectors at the manifold or stopcock¿.Subsequently, the luer collar does not tighten down at the manifold connection and it ¿frequently falls apart¿.Also, the male luer lock does not screw into the intravenous (iv) catheter hub; further described as, "the luer lock is seized in place and they cannot screw it down to the iv hub".This requires a new set to be obtained.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : three (3) used samples were received for evaluation.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.A functional testing and primed per directions was performed and no issues were noted.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: 9930794
• Report Number: 1416980-2020-02009
• Device Sequence Number: 2238481
• Product Code: FMG
• UDI-Device Identifier: 00085412035475
• UDI-Public: (01)00085412035475
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 05/06/2020

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: 2C6931
• Device Lot Number: DR19E29072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1