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

Catalog Number	2H8401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 a clearlink solution set was leaking.This event occurred during patient infusion of zoledronic acid while using an unspecified infusion pump.The location of the leak was not specified.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Two devices were received for evaluation: device #1: during visual inspection, a hole was observed in the tubing.Clear passage, pressure and functional testing were performed and the leak was confirmed due to a hole in the tubing.The reported condition was verified.The cause was determined to be a human error during the manufacturing process.Device #2: visual inspection did not identify any abnormalities that could have contributed to the reported condition.Clear passage, pressure and functional testing were all completed and performed according to product specifications.The reported condition 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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7276753
• Report Number: 1416980-2018-00811
• Device Sequence Number: 2273812
• Product Code: FPA
• UDI-Device Identifier: 00085412049090
• UDI-Public: (01)00085412049090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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 Expiration Date: 09/12/2022
• Device Catalogue Number: 2H8401
• Device Lot Number: R17I12031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/20/2018
• 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: ZOLEDRONIC ACID