MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8519

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

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 brown specks were stuck to the tubing of a clear-link system continu-flo solution set.The customer stated that, "it was hard to tell if it was melted plastic or if it was effecting the integrity of the tubing." this was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed contamination - particulate matter (pm) in the tubing.The pm was identified as irregular brown flecks embedded in multiple areas in the tubing due to a piece of burned plastic in the tubing.The reported condition of contamination was verified.The cause of the condition is manufacturing related.No additional defects were observed during inspection.The reported condition of damaged set-malformed was not verified.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: CLEARLINK CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10900010
• MDR Text Key: 218259348
• Report Number: 1416980-2020-07364
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048994
• UDI-Public: (01)00085412048994
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8519
• Device Lot Number: R20F25042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1