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

Catalog Number	2C6519
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event occurred on an unspecified date in (b)(6) 2020.(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the shipping label of the unknown quantity of continu-flo solution sets was placed over the barcode and product details.This was identified prior to use.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.Visual inspection was performed to the photograph which observed the shipping label was placed on top of the baxter label.The reported condition was verified.The cause of the condition is distribution center related.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: CONTINU-FLO INTERLINK SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10845488
• Report Number: 1416980-2020-07151
• Device Sequence Number: 14209538
• Product Code: FPA
• UDI-Device Identifier: 00085412002194
• UDI-Public: (01)00085412002194
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K123868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 2C6519
• Device Lot Number: R20F20043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1