MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8671
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfr address: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the flow was unable to be controlled on an unknown quantity of clearlink solution administration sets which resulted in free flow of medication.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with these events.No additional information is available.
Additional Manufacturer Narrative
Additional information : a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8947653
• Report Number: 1416980-2019-04723
• Device Sequence Number: 11402932
• Product Code: FPA
• UDI-Device Identifier: 00085412046334
• UDI-Public: (01)00085412046334
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 2C8671
• Device Lot Number: R19B21043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1