MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8612
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a clearlink system extension set leaked.During an unspecified surgical procedure, "the tubing split when the flow was increased and contents spilled." the tubing was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation contaminated with blood.A visual inspection was performed through the bag it arrived in, under a fume hood, which revealed a cut/slice/hole in the tubing.The reported condition was verified.Due to the nature of the sample, no functional testing was performed.The cause was determined to be due to the placement of the set in the packaging machine cavity which resulted in the tube being cut by the machine blade during the manufacturing process.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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9477570
• Report Number: 1416980-2019-06940
• Device Sequence Number: 16708866
• Product Code: FPA
• UDI-Device Identifier: 00085412070056
• UDI-Public: (01)00085412070056
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 2C8612
• Device Lot Number: R19I16030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED IV SOLUTION