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

Catalog Number	2C8515
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated the event occurred between the last week of (b)(6) 2020 and the first week of (b)(6) 2021.Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of an unspecified quantity of clearlink system continu-flo solution sets had minute holes and brown spots.This was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: a device was received for evaluation.Visual inspection was performed using the naked eye which observed irregular brown flecks embedded in tubing on multiple areas.The brown flecks were due to degraded pieces of burned plastic in the tubing.The visual inspection further identified marks on the tubing which does not impact functionality; no holes were found.Functional testing including pressure and clear passage tests were performed with no issues noted; no leak was observed.The reported condition of brown spots was verified.The cause of the burned plastic in the tubing was due to the manufacturing process.The report of minute holes 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11328028
• Report Number: 1416980-2021-00623
• Device Sequence Number: 934949
• Product Code: FPA
• UDI-Device Identifier: 00085412051703
• UDI-Public: (01)00085412051703
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K961225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 2C8515
• Device Lot Number: R20F10101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1