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	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 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 when removing the device from the original packaging, prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection was performed and a clear plastic with some white discoloration around the septum was observed in the connector.Functional testing was not performed for this complaint.The reported condition was verified.The cause of the condition was due to improper manual assembly during manufacturing.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: 12344424
• Report Number: 1416980-2021-05125
• Device Sequence Number: 4115862
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: Health Professional
• Device Catalogue Number: 1C8333
• Device Lot Number: R20K26058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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