MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE DUO-VENT INTERLINK SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C7452
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection via naked eye was done and observed embedded particular matters at the tip protector of the cannula lever lock.The reported condition was verified.The cause of the condition could not be determined.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.
Event or Problem Description
It was reported contaminants were observed inside "the cannula" of an interlink vented secondary medication set.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: DUO-VENT INTERLINK SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• MDR Report Key: 9107815
• Report Number: 1416980-2019-05222
• Device Sequence Number: 3588065
• Product Code: FPA
• UDI-Device Identifier: 00085412002583
• UDI-Public: (01)00085412002583
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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: 2C7452
• Device Lot Number: SR19D23108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1