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

Catalog Number 1C8333

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12344424
• MDR Text Key: 267334092
• Report Number: 1416980-2021-05125
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412013619
• UDI-Public: (01)00085412013619
• Combination Product (y/n): Y
• PMA/PMN Number: K811078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1