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

Catalog Number	1C8333
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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 particulate matter (pm) was observed within an interlink system blood bag spike injection site.The pm was further described as white discoloration around the septum.This issue was observed after spiking prior to patient use of the device.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4, and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that particulate matter (pm) contamination was observed in the connector.The pm was described as white discoloration around the septum of the device.Due to the nature of the returned sample, no additional tests could be performed.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.

• Brand Name: TRANSFER SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12221474
• Report Number: 1416980-2021-04560
• Device Sequence Number: 11752795
• Product Code: FPA
• UDI-Device Identifier: 00085412013619
• UDI-Public: (01)00085412013619
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 1C8333
• Device Lot Number: R20K26058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2020
• 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