MAUDE Adverse Event Report: INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3378
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 a interlink system non-dehp i.V.Catheter extension set leaked from an unspecified location.This was observed during testing with a saline syringe prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction b5: the location of the leak (omitted on initial) was reported to be at the point of attachment to the iv (intravenous) catheter hub (non-baxter product).Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The interlink inj site sub assembly was missing, however, an unknown non-baxter product was attached to the rest of the set.Additionally, it was observed that the set does not have a solvent bond between the interlink inj (injection) site and the winged female part.Dimensional testing was performed and the measure was within the specification range.Pressure testing was performed which revealed a leak between the female winged part and interlink inj site.The reported condition was verified.The cause of the condition could not be determined as the sample did not have all of its parts for proper evaluation.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12434314
• Report Number: 1416980-2021-05476
• Device Sequence Number: 14307912
• Product Code: FPA
• UDI-Device Identifier: 00085412004938
• UDI-Public: (01)00085412004938
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K925126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 2N3378
• Device Lot Number: UR21D13042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1